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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 K053636
Device Name MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE)
Applicant
Mani, Inc.
1301k St., NW
Suite 1100 - E. Tower
Washington,  DC  20005 -3373
Applicant Contact DAVID J BLOCH
Correspondent
Mani, Inc.
1301k St., NW
Suite 1100 - E. Tower
Washington,  DC  20005 -3373
Correspondent Contact DAVID J BLOCH
Regulation Number878.4493
Classification Product Code
GAM  
Date Received12/29/2005
Decision Date 03/14/2006
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
Recalls CDRH Recalls
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