The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Cefepime Dispans-o-disc (cefeplime - 30mcg).
| Device ID | K961148 |
| 510k Number | K961148 |
| Device Name: | CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG) |
| Classification | System, Transport, Aerobic |
| Applicant | DIFCO LABORATORIES, INC. 17197 N. LAUREL PARK SUITE 400 Livouia, MI 48152 |
| Contact | David Gates |
| Correspondent | David Gates DIFCO LABORATORIES, INC. 17197 N. LAUREL PARK SUITE 400 Livouia, MI 48152 |
| Product Code | JTW |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-21 |
| Decision Date | 1996-04-26 |