INTRAUTERINE DEVICE REMOVER
FDA 510(k) clearance K842295 · decided 1984-10-12
Clearance details
- K-number
- K842295
- Device name
- INTRAUTERINE DEVICE REMOVER
- Applicant
- Premier Dental Products Co.
- Decision
- Substantially Equivalent
- Date received
- 1984-06-11
- Decision date
- 1984-10-12
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- HHF
- Device class
- 1
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Norristown, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Premier Dental Products Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| RELIANCE TEMPO OPHTH. INSTR STAND (K831568) | F. & F. Koenigkramer | 1983-06-30 |
| 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.