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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K850714
Device Name C.A.D. PACK I -ARTHROSCOPY DRAPE PACK
Applicant
Concept, Inc.
12707 U.S. 19 S.
Clearwater,  FL  33546
Applicant Contact PENNY RASMUSSEN
Correspondent
Concept, Inc.
12707 U.S. 19 S.
Clearwater,  FL  33546
Correspondent Contact PENNY RASMUSSEN
Date Received02/22/1985
Decision Date 03/06/1985
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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