GENIE' SINGLE CEILING AND DOUBLE CEILING
FDA 510(k) clearance K963682 · decided 1996-11-13
Clearance details
- K-number
- K963682
- Device name
- GENIE' SINGLE CEILING AND DOUBLE CEILING
- Applicant
- Burton Medical Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-09-03
- Decision date
- 1996-11-13
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- FSY
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Chatsworth, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.