The following data is part of a premarket notification filed by Hunter Research Laboratories, Inc. with the FDA for Bull's-eye Disposable Needle Recapping Aid.
| Device ID | K002213 |
| 510k Number | K002213 |
| Device Name: | BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | HUNTER RESEARCH LABORATORIES, INC. 1541 SOUTH VINE ST. Denver, CO 80210 |
| Contact | Barbara Pedigo |
| Correspondent | Barbara Pedigo HUNTER RESEARCH LABORATORIES, INC. 1541 SOUTH VINE ST. Denver, CO 80210 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-21 |
| Decision Date | 2000-10-03 |