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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name negative pressure wound therapy powered suction pump
510(k) Number K122132
Device Name AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM
Applicant
MOLNLYCKE HEALTH CARE
5550 PEACHTREE PARKWAY
SUITE 500
NORCROSS,  GA  30092
Applicant Contact ANGELA L BUNN
Correspondent
MOLNLYCKE HEALTH CARE
5550 PEACHTREE PARKWAY
SUITE 500
NORCROSS,  GA  30092
Correspondent Contact ANGELA L BUNN
Regulation Number878.4780
Classification Product Code
OMP  
Date Received07/18/2012
Decision Date 01/17/2013
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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