The following data is part of a premarket notification filed by Molnlycke Health Care with the FDA for Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (small, Medium, Large) Avance Transparent Film Avance Foam.
Device ID | K122132 |
510k Number | K122132 |
Device Name: | AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM |
Classification | Negative Pressure Wound Therapy Powered Suction Pump |
Applicant | MOLNLYCKE HEALTH CARE 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092 |
Contact | Angela L Bunn |
Correspondent | Angela L Bunn MOLNLYCKE HEALTH CARE 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092 |
Product Code | OMP |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-07-18 |
Decision Date | 2013-01-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07323190023226 | K122132 | 000 |