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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, Synthetic, Polyethylene
510(k) Number K050150
Device Name MANI NEEDLE & SUTURE PACK
Applicant
Mani, Inc.
1301 K St., NW
Suite 1100
Washington,  DC  20005
Applicant Contact DAVID J BLOCH
Correspondent
Mani, Inc.
1301 K St., NW
Suite 1100
Washington,  DC  20005
Correspondent Contact DAVID J BLOCH
Regulation Number878.5000
Classification Product Code
GAT  
Subsequent Product Code
GDL  
Date Received01/24/2005
Decision Date 12/05/2005
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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