TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR*
FDA 510(k) clearance K864835 · decided 1987-02-11
Clearance details
- K-number
- K864835
- Device name
- TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR*
- Applicant
- Eisai U.S.A., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-12-09
- Decision date
- 1987-02-11
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- FCD
- Device class
- 1
- Regulation number
- 876.5210
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Torrance, 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 |
|---|---|---|
| PRO-FLO SYSTEM WITH INFRA-RED REMOTE CONTROL (K934585) | Lafayette Pharmaceuticals, Inc. | 1993-11-03 |
Recalls involving this device
No recalls on record reference this clearance.