The following data is part of a premarket notification filed by Safety 1st Medical, Inc. with the FDA for Safe-1(tm) Syringe.
| Device ID | K940635 |
| 510k Number | K940635 |
| Device Name: | SAFE-1(TM) SYRINGE |
| Classification | Syringe, Piston |
| Applicant | SAFETY 1ST MEDICAL, INC. 30100 TOWN CENTER DR. STE. O-290 Laguna Niguel, CA 92677 |
| Contact | Cheryl A Weatherford |
| Correspondent | Cheryl A Weatherford SAFETY 1ST MEDICAL, INC. 30100 TOWN CENTER DR. STE. O-290 Laguna Niguel, CA 92677 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-14 |
| Decision Date | 1995-01-31 |