The following data is part of a premarket notification filed by Laser Centers Of America, Inc. with the FDA for Hybrid Surgical Devices, Modificiation.
| Device ID | K951353 |
| 510k Number | K951353 |
| Device Name: | HYBRID SURGICAL DEVICES, MODIFICIATION |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | LASER CENTERS OF AMERICA, INC. 7840 MONTGOMERY RD. Cincinnati, OH 45236 |
| Contact | Richard L Studer |
| Correspondent | Richard L Studer LASER CENTERS OF AMERICA, INC. 7840 MONTGOMERY RD. Cincinnati, OH 45236 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-27 |
| Decision Date | 1995-04-06 |