ADAPTER FOR ELLIK EVACUATOR
FDA 510(k) clearance K760793 · decided 1976-10-15
Clearance details
- K-number
- K760793
- Device name
- ADAPTER FOR ELLIK EVACUATOR
- Applicant
- V. Mueller O.V. Baxter Healthcare Corp.
- Decision
- Substantially Equivalent
- Date received
- 1976-10-07
- Decision date
- 1976-10-15
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- FFD
- Device class
- 1
- Regulation number
- 876.4370
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| CUMEVAC (K874410) | Cumes-Honikman Partnership | 1987-12-03 |
Recalls involving this device
No recalls on record reference this clearance.