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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retention Device, Suture
510(k) Number K872608
Device Name HEWSON A.C.L. GUIDE SET
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
Regulation Number878.4930
Classification Product Code
KGS  
Date Received07/06/1987
Decision Date 09/16/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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