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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 K981322
Device Name CUTALON NYLON POLYAMIDE SURGICAL SUTURE
Applicant
Genzyme Surgical Product (Genzyme Biosurgery)
600 Airport Rd.
Fall River,  MA  02720
Applicant Contact JIM KENNEY
Correspondent
Genzyme Surgical Product (Genzyme Biosurgery)
600 Airport Rd.
Fall River,  MA  02720
Correspondent Contact JIM KENNEY
Regulation Number878.5020
Classification Product Code
GAR  
Date Received04/10/1998
Decision Date 07/07/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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