The following data is part of a premarket notification filed by Lafayette Pharmacal, Inc. with the FDA for Entrokit With Maglinte Catheter.
| Device ID | K860441 |
| 510k Number | K860441 |
| Device Name: | ENTROKIT WITH MAGLINTE CATHETER |
| Classification | Tube, Gastro-enterostomy |
| 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 | KGC |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-04 |
| Decision Date | 1986-03-12 |