The following data is part of a premarket notification filed by Innovatech Surgical Inc. with the FDA for Innovatech Straight Laser Probe, Model 420-10.
| Device ID | K032703 |
| 510k Number | K032703 |
| Device Name: | INNOVATECH STRAIGHT LASER PROBE, MODEL 420-10 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | INNOVATECH SURGICAL INC. 1000 ATLANTIC AVENUE SUITE 514 Camden, NJ 08104 |
| Contact | Michael J Mcgowan |
| Correspondent | Michael J Mcgowan INNOVATECH SURGICAL INC. 1000 ATLANTIC AVENUE SUITE 514 Camden, NJ 08104 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-02 |
| Decision Date | 2003-10-24 |
| Summary: | summary |