FDA Product Code
FDA Product Code FCD — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5210
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K934585 | PRO-FLO SYSTEM WITH INFRA-RED REMOTE CONTROL | Lafayette Pharmaceuticals, Inc. | 1993-11-03 | Traditional | PDF ↗ |
| K864835 | TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR* | Eisai U.S.A., Inc. | 1987-02-11 | Traditional | PDF ↗ |
Product code FCD · Class I · Gastroenterology, Urology. Data: openFDA.