POLYURETHANE SOLUTION 29% W/W
FDA 510(k) clearance K944934 · decided 1994-12-09
Clearance details
- K-number
- K944934
- Device name
- POLYURETHANE SOLUTION 29% W/W
- Applicant
- Knowell Therapeutic Technologies,Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-10-06
- Decision date
- 1994-12-09
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- LBH
- Device class
- 2
- Regulation number
- 872.3260
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Toronto, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.