VAGINAL RETRACTORS - KRISTELLER, DELEE, BREISKY
FDA 510(k) clearance K891038 · decided 1989-03-17
Clearance details
- K-number
- K891038
- Device name
- VAGINAL RETRACTORS - KRISTELLER, DELEE, BREISKY
- 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
- HDL
- Device class
- 1
- Regulation number
- 884.4520
- 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 RETRACTOR (K780349) | Edward Weck, Inc. | 1978-03-14 |
Recalls involving this device
No recalls on record reference this clearance.