SURGICAL MASK
FDA 510(k) clearance K801036 · decided 1980-06-04
Clearance details
- K-number
- K801036
- Device name
- SURGICAL MASK
- Applicant
- American Threshold Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-05-02
- Decision date
- 1980-06-04
- Days to decision
- 33 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
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Supergrade Earloop Masks, surgical mask; 50 masks per box; Distributed by Safco Dental Sup recall (Z-0944-03) | Safco Dental Supply Co. Inc. | 2003-06-21 |