The following data is part of a premarket notification filed by Lafayette Pharmacal, Inc. with the FDA for Pro-flo System.
| Device ID | K931896 |
| 510k Number | K931896 |
| Device Name: | PRO-FLO SYSTEM |
| Classification | Enema Kit |
| Applicant | LAFAYETTE PHARMACAL, INC. 522 N. EARL AVE. Lafayette, IN 47903 |
| Contact | Robert A Sharp |
| Correspondent | Robert A Sharp LAFAYETTE PHARMACAL, INC. 522 N. EARL AVE. Lafayette, IN 47903 |
| Product Code | FCE |
| CFR Regulation Number | 876.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-15 |
| Decision Date | 1993-08-26 |
| Summary: | summary |