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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K874219
Device Name S3 MEDICATED GAUZE
Applicant
Surgical Specialties, Inc.
P.O. Box 310
Readding,  PA  19607
Applicant Contact GEORGE ERL
Correspondent
Surgical Specialties, Inc.
P.O. Box 310
Readding,  PA  19607
Correspondent Contact GEORGE ERL
Classification Product Code
FRO  
Date Received10/16/1987
Decision Date 11/23/1987
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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