RELIANCE TEMPO OPHTH. INSTR STAND
FDA 510(k) clearance K831568 · decided 1983-06-30
Clearance details
- K-number
- K831568
- Device name
- RELIANCE TEMPO OPHTH. INSTR STAND
- Applicant
- F. & F. Koenigkramer
- Decision
- Substantially Equivalent
- Date received
- 1983-05-16
- Decision date
- 1983-06-30
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- HHF
- Device class
- 1
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Walker, MI, 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 |
|---|---|---|
| IUD HOOKS (K926541) | Thomasville Medical Assoc. | 1994-02-24 |
| IUD HOOKS - SIMPLE, UNIVERSAL AND SKLAR (K891030) | Zinnanti Surgical Instruments, Inc. | 1989-03-17 |
| INTRAUTERINE DEVICE REMOVER (K842295) | Premier Dental Products Co. | 1984-10-12 |
| EMMETT IUD THREAD RETREIVER (K820115) | Proto-Med, Inc. | 1982-02-05 |
| THE EMMETT IUD THREAD RETRIEVER (K811761) | Proto-Med, Inc. | 1981-09-21 |
Recalls involving this device
No recalls on record reference this clearance.