DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560
FDA 510(k) clearance K061864 · decided 2006-09-15
Clearance details
- K-number
- K061864
- Device name
- DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560
- Applicant
- Dukal Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-07-03
- Decision date
- 2006-09-15
- Days to decision
- 74 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
- Hauppauge, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.