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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Surgical, Absorbable, Polydioxanone
510(k) Number K120284
Device Name DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX
Applicant
Coloplast A/S
1601 W. River Rd. N.
Plymouth,  MN  55411
Applicant Contact JANELL COLLEY
Correspondent
Coloplast A/S
1601 W. River Rd. N.
Plymouth,  MN  55411
Correspondent Contact JANELL COLLEY
Regulation Number878.4840
Classification Product Code
NEW  
Subsequent Product Code
GAM  
Date Received01/31/2012
Decision Date 05/23/2012
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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