The following data is part of a premarket notification filed by Med-safe Systems, Inc. with the FDA for B-d Guardian Point Of Use Horizontal And Side Entry Sharps Collectors.
| Device ID | K943141 |
| 510k Number | K943141 |
| Device Name: | B-D GUARDIAN POINT OF USE HORIZONTAL AND SIDE ENTRY SHARPS COLLECTORS |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MED-SAFE SYSTEMS, INC. 4665 NORTH AVE. Oceanside, CA 92056 -3590 |
| Contact | Virginia M Shillington |
| Correspondent | Virginia M 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 |
|---|---|---|
| 00382903056224 | K943141 | 000 |
| 50382903054232 | K943141 | 000 |
| 50382903054225 | K943141 | 000 |
| 50382903053303 | K943141 | 000 |
| 50382903051514 | K943141 | 000 |
| 50382903050791 | K943141 | 000 |
| 50382903050579 | K943141 | 000 |
| 50382903050562 | K943141 | 000 |
| 50382903050555 | K943141 | 000 |
| 50382903050548 | K943141 | 000 |
| 50382903054256 | K943141 | 000 |
| 50382903054263 | K943141 | 000 |
| 50382903054270 | K943141 | 000 |
| 00382903055517 | K943141 | 000 |
| 00382903055432 | K943141 | 000 |
| 00382903055173 | K943141 | 000 |
| 00382903054442 | K943141 | 000 |
| 00382903054435 | K943141 | 000 |
| 00382903054367 | K943141 | 000 |
| 00382903054350 | K943141 | 000 |
| 50382903055505 | K943141 | 000 |
| 50382903054287 | K943141 | 000 |
| 50382903050531 | K943141 | 000 |