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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polyamide
510(k) Number K932037
Device Name SUTURE ABSORBABLE- GUT
Applicant
Surgical Specialties, Inc.
P.O. Box 310
Readding,  PA  19607
Applicant Contact LINDA TEXTER
Correspondent
Surgical Specialties, Inc.
P.O. Box 310
Readding,  PA  19607
Correspondent Contact LINDA TEXTER
Regulation Number878.5020
Classification Product Code
GAR  
Date Received04/27/1993
Decision Date 01/07/1994
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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