The following data is part of a premarket notification filed by Mdc Research Ltd. with the FDA for Mdc Safe Step Safety Blood Collection Needle System.
| Device ID | K973012 |
| 510k Number | K973012 |
| Device Name: | MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MDC RESEARCH LTD. 2810 BUNSEN AVE. Ventura, CA 93003 |
| Contact | James M Donegan |
| Correspondent | James M Donegan MDC RESEARCH LTD. 2810 BUNSEN AVE. Ventura, CA 93003 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-13 |
| Decision Date | 1997-11-05 |
| Summary: | summary |