QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING
FDA 510(k) clearance DEN070002 · decided 2009-02-25
Clearance details
- K-number
- DEN070002
- Device name
- QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING
- Applicant
- Quick-Med Technologies, Inc.
- Decision
- Unknown
- Date received
- 2007-05-10
- Decision date
- 2009-02-25
- Days to decision
- 657 days
- Clearance type
- Post-NSE
- Product code
- NYS
- Device class
- 2
- Regulation number
- 878.4015
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Gainesville, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.