SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP
FDA 510(k) clearance K063043 · decided 2007-03-21
Clearance details
- K-number
- K063043
- Device name
- SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP
- Applicant
- Modern Healthcare Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-10-03
- Decision date
- 2007-03-21
- Days to decision
- 169 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
- Hsin-Chu City, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.