WEIGHTED SPECULA-STEINER,HENROTIN,BERLAND,GARRIGUE
FDA 510(k) clearance K891037 · decided 1989-03-17
Clearance details
- K-number
- K891037
- Device name
- WEIGHTED SPECULA-STEINER,HENROTIN,BERLAND,GARRIGUE
- Applicant
- Zinnanti Surgical Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-02-28
- Decision date
- 1989-03-17
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- HFD
- Device class
- 2
- Regulation number
- 884.1185
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Chatsworth, 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 |
|---|---|---|
| VAGINAL SPECULUM (K890376) | Kinetic Medical Products | 1989-02-27 |
| SKIN SCRUB TRAY (K810558) | Associated Medical Products Co. | 1981-03-17 |
Recalls involving this device
No recalls on record reference this clearance.