FDA Denial

Excerpt from exhibit Exhibit E

To attempt to handle this by phone after receiving a letter from Mariam C. Provost for Donna-Bea Tillman Ph.D. on August 3, 2005, which she implied, "that letter was a generic letter". We then believed, that letter was not the answer to our question about Sec.880.9, it was a generic reply.

Sheila Murphy, Inspection Device Control Branch, agreed, by phone, that we were in the wrong classification and she would put the request to change to another department. Obviously this never happoned, or if it did, it was ignored.

Earlier, by phone, Jake Romanell, 513g coordinator, also agreed that we were in the wrong category.

FOLLOWED BY A LETTER DATED July 6, 2005 from:
Donna-Bea Tillman, Ph. D. j Director
Office of Device Evaluation
Center for Devices and Radiological Health

Quote: "Based on the information provided in your submission, we believe that the Odatus Air Purifier falls within Title 21 of the Code of Federal Regulations (CFR) 880.5045,"
and "A medical recirculating air cleaner is a Class II type device. Therefore you will need to submit a premarket notification [5l0(k ..."  
and ended with: " Mr. John O. Shannon - If you have any questions regarding this letter, please contact Sheila Murphy, M.D., Chief, Infection Control Devices Branch, at (301) 594-1287, or for general questions please contact the Division of Small Manufacturers International and Consumer Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html."

It appears obvious that Mrs. Tillman concluded FDA's business with us. It is also obvious that she either did not review or ignored Sheila Murphy's request to change our classification to another department.

We had no intentions to list our devices under 510(K) and had no reason to submit a premarket notification 510(K) as suggested in Ms. Tillman's letter. We didn't.

We have manufactured and marketed these products since 1990 and saw no reason to discontinue at that point. We never needed FDA labeling and see no future advantages in acquiring one.

 John O. Shannon, President

CareTech Industries, Inc.