The following data is part of a premarket notification filed by Med-safe Systems, Inc. with the FDA for B-d Guradian Chemotherapy Sharps Collectors.
| Device ID | K943140 |
| 510k Number | K943140 |
| Device Name: | B-D GURADIAN CHEMOTHERAPY SHARPS COLLECTORS |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MED-SAFE SYSTEMS, INC. 4665 NORTH AVE. Oceanside, CA 92056 -3590 |
| Contact | Virginia Shillington |
| Correspondent | Virginia Shillington MED-SAFE SYSTEMS, INC. 4665 NORTH AVE. Oceanside, CA 92056 -3590 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-29 |
| Decision Date | 1994-11-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382903056149 | K943140 | 000 |
| 00382903056132 | K943140 | 000 |
| 00382903056040 | K943140 | 000 |
| 00382903056033 | K943140 | 000 |
| 00382903055784 | K943140 | 000 |
| 00382903054930 | K943140 | 000 |
| 50382903051149 | K943140 | 000 |
| 50382903050760 | K943140 | 000 |