AMSEAL SURGICAL FACE MASK
FDA 510(k) clearance K964358 · decided 1997-02-14
Clearance details
- K-number
- K964358
- Device name
- AMSEAL SURGICAL FACE MASK
- Applicant
- American Seal Co.
- Decision
- Substantially Equivalent
- Date received
- 1996-11-01
- Decision date
- 1997-02-14
- Days to decision
- 105 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
- Hayward, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, recall (Z-1451-2013) | Maytex Corp | 2013-06-04 |