CHISELS- FREER, LUCAS, ALEXANDER, BISHOP
FDA 510(k) clearance K891902 · decided 1989-04-12
Clearance details
- K-number
- K891902
- Device name
- CHISELS- FREER, LUCAS, ALEXANDER, BISHOP
- Applicant
- Zinnanti Surgical Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-03-24
- Decision date
- 1989-04-12
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- KGD
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- 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 |
|---|---|---|
| POWDER FREE SURGEON'S GLOVE (K944054) | Arent Fox | 1994-11-17 |
Recalls involving this device
No recalls on record reference this clearance.