INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP
FDA 510(k) clearance K042267 · decided 2004-09-30
Clearance details
- K-number
- K042267
- Device name
- INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP
- Applicant
- Inovel, LLC
- Decision
- Substantially Equivalent
- Date received
- 2004-08-23
- Decision date
- 2004-09-30
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- MSH
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Culver City, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Inovel N95 HealthCare Particulate Respirator, Model/Catalog Number: FRN95-SEZ, Expiration recall (Z-1576-2009) | Inovel LLC | 2009-07-13 |