IMPLANT MEASURING GAUGE
FDA 510(k) clearance K833606 · decided 1984-01-03
Clearance details
- K-number
- K833606
- Device name
- IMPLANT MEASURING GAUGE
- Applicant
- Microtek Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-10-12
- Decision date
- 1984-01-03
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- JYJ
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Mchenry, IL, 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 |
|---|---|---|
| EYEOPENER (K904469) | Kc Medical Industries | 1991-06-28 |
| ACCESSORY TO EYEDROP GUIDE (K884974) | Suredrop, Inc. | 1989-03-24 |
| SUREDROP EYEDROP GUIDE (K874569) | Suredrop, Inc. | 1988-05-03 |
| RHINOMETER (K801938) | Aztec Medical Products, Inc. | 1980-09-09 |
Recalls involving this device
No recalls on record reference this clearance.