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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, Silk
510(k) Number K930826
Device Name SUTURE NONABSORBABLE - SILK
Applicant
SURGICAL SPECIALTIES, INC.
P.O. BOX 310
READING,  PA  19607
Applicant Contact LINDA TEXTER
Correspondent
SURGICAL SPECIALTIES, INC.
P.O. BOX 310
READING,  PA  19607
Correspondent Contact LINDA TEXTER
Regulation Number878.5030
Classification Product Code
GAP  
Date Received02/17/1993
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
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