FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM
K Number: K122132
·
Decision Jan 17, 2013
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
204
Applicant Total
7
Review Days
183
Basic Information
- Device Name
- AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM
- K Number
- K122132
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MOLNLYCKE HEALTH CARE
- Date Received
- July 18, 2012
- Decision Date
- January 17, 2013
- Product Code
- OMP
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | FDA class 2 | General, Plastic Surgery |
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Other Clearances by MOLNLYCKE HEALTH CARE
| K Number | Device Name | ||
|---|---|---|---|
| K130040 | MEPITEL AG | Feb 12, 2014 | Substantially Equivalent |
| K123892 | MEPILEX TRANSFER AG | Apr 5, 2013 | Substantially Equivalent |
| K100029 | MEPILEX BORDER AG DRESSING | Sep 15, 2010 | Substantially Equivalent |
| K061554 | MEPILEX AG ABSORBENT SILICONE-COATED DRESSING | Jan 25, 2007 | Substantially Equivalent |
| K050786 | BARRIER SURGICAL GOWNS | May 9, 2005 | Substantially Equivalent |
| K031131 | KLINIDRAPE SURGICAL DRAPES | Jun 10, 2003 | Substantially Equivalent |