The following data is part of a premarket notification filed by Biosafety Systems, Inc. with the FDA for Chemoguard, P2 Hirisk.
| Device ID | K952274 |
| 510k Number | K952274 |
| Device Name: | CHEMOGUARD, P2 HIRISK |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BIOSAFETY SYSTEMS, INC. 10225 WILLOW CREEK RD. San Diego, CA 92131 |
| Contact | Daniel J Kun |
| Correspondent | Daniel J Kun BIOSAFETY SYSTEMS, INC. 10225 WILLOW CREEK RD. San Diego, CA 92131 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-15 |
| Decision Date | 1995-08-29 |