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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K842356
Device Name CUSTOM STERILE PROCEDURE KITS
Applicant
Sterile Design, Inc.
P.O. Box 12100
Oldsmar,  FL  34677
Applicant Contact JOHN C HOFFMAN
Correspondent
Sterile Design, Inc.
P.O. Box 12100
Oldsmar,  FL  34677
Correspondent Contact JOHN C HOFFMAN
Date Received06/15/1984
Decision Date 03/21/1985
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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