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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, absorbable, synthetic, polyglycolic acid
510(k) Number K003017
Device Name GRAMSORB SYNTHETIC ABSORBABLE SUTURE
Applicant
GRAMSMED LLC
2225 DAKOTA DR.
GRAFTON,  WI  53024
Applicant Contact A. J DIMERCURIO
Correspondent
GRAMSMED LLC
2225 DAKOTA DR.
GRAFTON,  WI  53024
Correspondent Contact A. J DIMERCURIO
Regulation Number878.4493
Classification Product Code
GAM  
Date Received09/27/2000
Decision Date 03/13/2001
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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