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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 K930517
Device Name NON-ABSORBABLE SURGICAL SUTURES
Applicant
Alcon Laboratories
6201 S. Fwy. R7-14
Fort Worth,  TX  76134
Applicant Contact DAVID KRAPF
Correspondent
Alcon Laboratories
6201 S. Fwy. R7-14
Fort Worth,  TX  76134
Correspondent Contact DAVID KRAPF
Regulation Number878.5020
Classification Product Code
GAR  
Subsequent Product Codes
GAP   GAS   GAT   GAW  
Date Received02/01/1993
Decision Date 12/17/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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