The following data is part of a premarket notification filed by Surgical Technologies, Inc. with the FDA for Surgical Technologies, Inc. Syringe.
| Device ID | K951918 |
| 510k Number | K951918 |
| Device Name: | SURGICAL TECHNOLOGIES, INC. SYRINGE |
| Classification | Syringe, Piston |
| Applicant | SURGICAL TECHNOLOGIES, INC. 2801 SOUTH DECKER LAKE LN. Salt Lake City, UT 84119 |
| Contact | John E Lincoln |
| Correspondent | John E Lincoln SURGICAL TECHNOLOGIES, INC. 2801 SOUTH DECKER LAKE LN. Salt Lake City, UT 84119 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-24 |
| Decision Date | 1995-07-20 |