CATCO NEONATAL PALATE GUARD
FDA 510(k) clearance K945727 · decided 1994-12-07
Clearance details
- K-number
- K945727
- Device name
- CATCO NEONATAL PALATE GUARD
- Applicant
- Catco Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-11-22
- Decision date
- 1994-12-07
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- BRW
- Device class
- 1
- Regulation number
- 868.5820
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| WILEY/ESPOSITO DENTAL GUARD (K935713) | Fvtnks | 1994-01-05 |
| TIP TOLEDO INCISOR PROTECTOR (K851640) | Edward O. Goodwich | 1985-09-18 |
Recalls involving this device
No recalls on record reference this clearance.