NON-STERILE SURGICAL MASK
FDA 510(k) clearance K051291 · decided 2005-09-20
Clearance details
- K-number
- K051291
- Device name
- NON-STERILE SURGICAL MASK
- Applicant
- A.R. Medicom, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-05-18
- Decision date
- 2005-09-20
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- FXX
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Lachine (Montreal), CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HENRY SCHEIN CRITERION EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448) recall (Z-1146-2024) | AMD Medicom Inc. | 2024-02-16 |
| HENRY SCHEIN CRITERION ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281) recall (Z-1147-2024) | AMD Medicom Inc. | 2024-02-16 |
| PATTERSON PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573) recall (Z-1148-2024) | AMD Medicom Inc. | 2024-02-16 |