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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal
510(k) Number K861445
Device Name S1 CAVITY PACKING
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
EFQ  
Date Received04/17/1986
Decision Date 05/06/1986
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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