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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 K760158
Device Name NEEDLES AND SUTURES, SILK & NYLON
Applicant
Alcon Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Alcon Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.5030
Classification Product Code
GAP  
Date Received07/02/1976
Decision Date 08/19/1976
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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