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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 K050771
Device Name LUPINE LOOP
Applicant
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
249 VANDERBILT AVE.
NORWOOD,  MA  02062
Applicant Contact DENISE LUCIANO
Correspondent
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
249 VANDERBILT AVE.
NORWOOD,  MA  02062
Correspondent Contact DENISE LUCIANO
Regulation Number878.4493
Classification Product Code
GAM  
Subsequent Product Code
MAI  
Date Received03/25/2005
Decision Date 04/08/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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