The following data is part of a premarket notification filed by Surgical Technologies, Inc. with the FDA for Surg Tech,inc. 30 Gauge Straight Extrusion Needles.
| Device ID | K910036 |
| 510k Number | K910036 |
| Device Name: | SURG TECH,INC. 30 GAUGE STRAIGHT EXTRUSION NEEDLES |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | SURGICAL TECHNOLOGIES, INC. 750 GODDARD AVE. Chesterfield, MO 63005 |
| Contact | Todd J Hessel |
| Correspondent | Todd J Hessel SURGICAL TECHNOLOGIES, INC. 750 GODDARD AVE. Chesterfield, MO 63005 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-04 |
| Decision Date | 1991-04-04 |