The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Dispens-o-disc (tm) Levofloxacin.
| Device ID | K971120 |
| 510k Number | K971120 |
| Device Name: | DISPENS-O-DISC (TM) LEVOFLOXACIN |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | DIFCO LABORATORIES, INC. 920 HENRY ST. Detroit, MI 48201 |
| Contact | David W Gates |
| Correspondent | David W Gates DIFCO LABORATORIES, INC. 920 HENRY ST. Detroit, MI 48201 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-27 |
| Decision Date | 1997-04-14 |