The following data is part of a premarket notification filed by Surgical Technologies, Inc. with the FDA for Infinitech Soft Tip Flute Needle.
| Device ID | K946181 |
| 510k Number | K946181 |
| Device Name: | INFINITECH SOFT TIP FLUTE NEEDLE |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | SURGICAL TECHNOLOGIES, INC. 750 GODDARD AVE. Chesterfield, MO 63005 |
| Contact | Alan T Beckman |
| Correspondent | Alan T Beckman SURGICAL TECHNOLOGIES, INC. 750 GODDARD AVE. Chesterfield, MO 63005 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-20 |
| Decision Date | 1995-03-14 |