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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, Polypropylene
510(k) Number K093112
Device Name DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE
Applicant
COLOPLAST MANUFACTURING US, LLC
1601 WEST RIVER ROAD
MINNEAPOLIS,  MN  55411
Applicant Contact JANELL COLLEY
Correspondent
COLOPLAST MANUFACTURING US, LLC
1601 WEST RIVER ROAD
MINNEAPOLIS,  MN  55411
Correspondent Contact Kelley Breheim
Regulation Number878.5010
Classification Product Code
GAW  
Subsequent Product Code
HCF  
Date Received10/01/2009
Decision Date 02/01/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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