Tuesday May 6, 2008

Mr. Leroy Terrelonge
Florida District's Recall and Emergency Coordinator

Mr. Leroy Terrelonge,
I thank you for your phone call yesterday and your emailing a copy of the Recall Report Format Questionnaire. As you mentioned, you have no knowledge of this recall or why and asked for copies of the FDA letters to help me figure-out a recall. I excerpted a paragraph from another letter being written by me. This will give you a jump start on the FDA warnings and their final letter.

"Since we have never submitted a premarket notification 510(K), as suggested by Donna-Bea Tillman, Ph. D. j Director's letter of 513g request denial, quoting: "you will need to submit a premarket notification [5l0(k)]" (Exhibit J), none of the following events or letters should have ever taken place. This is further explained in Exhibit J2."

Reply to Matthew B Thomaston, Compliance Officer, warning letters

Matthew B Thomaston, Compliance Officer, final letter that ends with "you do not need to respond to this letter. We will verify corrections made by your firm, if any, during our next visit.

RETURNING TO YOU: Recall Report Format Questionnaire

Your kind help is most appreciated.

John. O. Shannon, IEE, CES, PCA
President
Care Tech Industries, Inc.

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