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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 K903177
Device Name ADVANCE SUTURE NONABSORBABLE NYLON SUTURE
Applicant
ADVANCE SUTURE, INC.
P.O. BOX 12428
TUCSON,  AZ  85732
Applicant Contact DANIEL MISENHIMER
Correspondent
ADVANCE SUTURE, INC.
P.O. BOX 12428
TUCSON,  AZ  85732
Correspondent Contact DANIEL MISENHIMER
Regulation Number878.5020
Classification Product Code
GAR  
Date Received07/18/1990
Decision Date 06/28/1991
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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