The following data is part of a premarket notification filed by Smiths Industries Medical Systems, Inc. with the FDA for Sharpsafe Cat. No. 4127.
| Device ID | K935628 |
| 510k Number | K935628 |
| Device Name: | SHARPSAFE CAT. NO. 4127 |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 KIT ST. Keene, NH 03431 |
| Contact | Timothy J Talcott |
| Correspondent | Timothy J Talcott SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 KIT ST. Keene, NH 03431 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-23 |
| Decision Date | 1994-02-04 |