2505 FACE MASK, TIE STRING / ANTI-FOG / FACE SHIELD
FDA 510(k) clearance K962286 · decided 1996-10-07
Clearance details
- K-number
- K962286
- Device name
- 2505 FACE MASK, TIE STRING / ANTI-FOG / FACE SHIELD
- Applicant
- Berkley Medical Resources, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-06-14
- Decision date
- 1996-10-07
- Days to decision
- 115 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
- Uniontown, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.