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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 K003590
Device Name GRAMS POLYESTER NONABSORBABLE SUTURE
Applicant
Gramsmed, LLC
2225 Dakota Dr.
Grafton,  WI  53024
Applicant Contact ANTHONY J DIMERCURIO
Correspondent
Gramsmed, LLC
2225 Dakota Dr.
Grafton,  WI  53024
Correspondent Contact ANTHONY J DIMERCURIO
Regulation Number878.5000
Classification Product Code
GAT  
Date Received11/21/2000
Decision Date 03/05/2001
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
Predetermined Change
Control Plan Authorized		 No
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