ORALLITE COMPREHENSIVE EXAM TRAY
FDA 510(k) clearance K012070 · decided 2001-11-27
Clearance details
- K-number
- K012070
- Device name
- ORALLITE COMPREHENSIVE EXAM TRAY
- Applicant
- Trylon Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-02
- Decision date
- 2001-11-27
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- MPU
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Torrance, CA, 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 |
|---|---|---|
| SPECULITE (K963391) | Trylon Corp. | 1997-12-12 |
Recalls involving this device
No recalls on record reference this clearance.