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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, Natural
510(k) Number K021043
Device Name GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC
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 Number878.4830
Classification Product Code
GAL  
Date Received04/01/2002
Decision Date 06/21/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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