ACTIPROTECT UC N95 RESPIRATOR
FDA 510(k) clearance K093189 · decided 2010-07-02
Clearance details
- K-number
- K093189
- Device name
- ACTIPROTECT UC N95 RESPIRATOR
- Applicant
- Glaxosmithkline Consumer Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2009-10-09
- Decision date
- 2010-07-02
- Days to decision
- 266 days
- Clearance type
- Abbreviated
- Product code
- ORW
- Device class
- 2
- Regulation number
- 880.6260
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Parsippany, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.