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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 K905454
Device Name ADVANCE SUTURE NONABSORBABLE SILK SUTURE
Applicant
Advance Suture, Inc.
P.O. Box 12428
Tucson,  AZ  85732
Applicant Contact DANIEL P MISENHIMER
Correspondent
Advance Suture, Inc.
P.O. Box 12428
Tucson,  AZ  85732
Correspondent Contact DANIEL P MISENHIMER
Regulation Number878.5030
Classification Product Code
GAP  
Date Received12/05/1990
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
Predetermined Change
Control Plan Authorized		 No
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