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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 K001440
Device Name NEXTSTITCH CARDIOVASCULAR VALVE 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 11/13/2000
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
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