RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU
FDA 510(k) clearance K892542 · decided 1989-05-09
Clearance details
- K-number
- K892542
- Device name
- RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU
- Applicant
- Zinnanti Surgical Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-04-11
- Decision date
- 1989-05-09
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- FFN
- Device class
- 1
- Regulation number
- 876.4730
- 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 |
|---|---|---|
| AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS (K932408) | Baxter Healthcare Corp | 1993-09-28 |
| BEST COLON CLAMP (K892550) | Zinnanti Surgical Instruments, Inc. | 1989-05-09 |
| TUBING CLAMP (K772405) | Fred Sammons, Inc. | 1978-01-26 |
| CATHETEO CLAMP (K771421) | Quinton, Inc. | 1977-10-25 |
Recalls involving this device
No recalls on record reference this clearance.