The following data is part of a premarket notification filed by Mdc Research Ltd. with the FDA for Mdc Safe Step Safety I.v. Catheter System.
| Device ID | K960013 |
| 510k Number | K960013 |
| Device Name: | MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | MDC RESEARCH LTD. 2810 BUNSEN AVE. Ventura, CA 93003 |
| Contact | John Botich |
| Correspondent | John Botich MDC RESEARCH LTD. 2810 BUNSEN AVE. Ventura, CA 93003 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-02 |
| Decision Date | 1996-02-13 |