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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 K041806
Device Name PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE; AND PASSING NEEDLE WITH ETHIBOND LOOP
Applicant
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
249 VANDERBILT AVE.
NORWOOD,  MA  02062
Applicant Contact RUTH C FORSTADT
Correspondent
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
249 VANDERBILT AVE.
NORWOOD,  MA  02062
Correspondent Contact RUTH C FORSTADT
Regulation Number878.4493
Classification Product Code
GAM  
Subsequent Product Codes
GAT   NEW  
Date Received07/06/2004
Decision Date 08/03/2004
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
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