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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, polyethylene
510(k) Number K001434
Device Name 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE
Applicant
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
600 AIRPORT RD.
FALL RIVER,  MA  02720 -4740
Applicant Contact MARY E GRAY
Correspondent
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
600 AIRPORT RD.
FALL RIVER,  MA  02720 -4740
Correspondent Contact MARY E GRAY
Regulation Number878.5000
Classification Product Code
GAT  
Date Received05/08/2000
Decision Date 06/12/2000
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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