CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING
FDA 510(k) clearance K946338 · decided 1995-03-29
Clearance details
- K-number
- K946338
- Device name
- CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING
- Applicant
- Certified Safety Mfg., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-12-29
- Decision date
- 1995-03-29
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- MGP
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Kansas City, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.