The following data is part of a premarket notification filed by Surgical Technologies, Inc. with the FDA for Infinitech Aspirating Laser Probe.
| Device ID | K946135 |
| 510k Number | K946135 |
| Device Name: | INFINITECH ASPIRATING LASER PROBE |
| 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 | 1994-12-16 |
| Decision Date | 1995-04-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10380657525567 | K946135 | 000 |
| 10380657525550 | K946135 | 000 |
| 10380657525543 | K946135 | 000 |