The following data is part of a premarket notification filed by Lafayette Pharmaceuticals, Inc. with the FDA for Pro-flo System With Infra-red Remote Control.
| Device ID | K934585 |
| 510k Number | K934585 |
| Device Name: | PRO-FLO SYSTEM WITH INFRA-RED REMOTE CONTROL |
| Classification | Barium Enema Kit |
| Applicant | LAFAYETTE PHARMACEUTICALS, INC. 522 N. EARL AVE. P.O. BOX 4499 Lafayette, IN 47903 |
| Contact | Robert A Sharp |
| Correspondent | Robert A Sharp LAFAYETTE PHARMACEUTICALS, INC. 522 N. EARL AVE. P.O. BOX 4499 Lafayette, IN 47903 |
| Product Code | FCD |
| CFR Regulation Number | 876.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-23 |
| Decision Date | 1993-11-03 |