TIP TOLEDO INCISOR PROTECTOR
FDA 510(k) clearance K851640 · decided 1985-09-18
Clearance details
- K-number
- K851640
- Device name
- TIP TOLEDO INCISOR PROTECTOR
- Applicant
- Edward O. Goodwich
- Decision
- Substantially Equivalent
- Date received
- 1985-04-11
- Decision date
- 1985-09-18
- Days to decision
- 160 days
- Clearance type
- Traditional
- Product code
- BRW
- Device class
- 1
- Regulation number
- 868.5820
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Narberth, PA, 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 |
|---|---|---|
| CATCO NEONATAL PALATE GUARD (K945727) | Catco Medical, Inc. | 1994-12-07 |
| WILEY/ESPOSITO DENTAL GUARD (K935713) | Fvtnks | 1994-01-05 |
Recalls involving this device
No recalls on record reference this clearance.