MOBLVAC W.C.
FDA 510(k) clearance K081185 · decided 2008-05-02
Clearance details
- K-number
- K081185
- Device name
- MOBLVAC W.C.
- Applicant
- Ohio Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2008-04-25
- Decision date
- 2008-05-02
- Days to decision
- 7 days
- Clearance type
- Special
- Product code
- BTA
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Gurnee, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MoblVac Portable Wound Care Pump; an AC/DC powered portable aspirator that provides negati recall (Z-1777-2010) | Ohio Medical Corporation | 2010-06-07 |
| NPWT Small Mobile Bag No Logo; an adjunct to the MoblVac Portable Wound Care Pump; Ohio Me recall (Z-1778-2010) | Ohio Medical Corporation | 2010-06-07 |