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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, silk
510(k) Number K053638
Device Name MANI NEEDLE & SUTURE PACK (SILK)
Applicant
MANI, INC.
1301K STREET, N.W.
SUITE 1100 - EAST TOWER
WASHINGTON,  DC  20005 -3373
Applicant Contact DAVID J BLOCH
Correspondent
MANI, INC.
1301K STREET, N.W.
SUITE 1100 - EAST TOWER
WASHINGTON,  DC  20005 -3373
Correspondent Contact DAVID J BLOCH
Regulation Number878.5030
Classification Product Code
GAP  
Date Received12/29/2005
Decision Date 05/19/2006
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
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