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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, Polypropylene
510(k) Number K010909
Device Name NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE
Applicant
Tyco Healthcare Group LP
150 Glover Ave.
Norwalk,  CT  06856
Applicant Contact ROBERT ZOTT
Correspondent
Tyco Healthcare Group LP
150 Glover Ave.
Norwalk,  CT  06856
Correspondent Contact ROBERT ZOTT
Regulation Number878.5010
Classification Product Code
GAW  
Date Received03/26/2001
Decision Date 04/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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