The following data is part of a premarket notification filed by Klinger Medical with the FDA for Model Mc 2100 Nd:yag Surgical Laser System.
| Device ID | K901340 |
| 510k Number | K901340 |
| Device Name: | MODEL MC 2100 ND:YAG SURGICAL LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | KLINGER MEDICAL 27812 RUISENOR Mission Viejo, CA 92691 |
| Contact | Michael Moretti |
| Correspondent | Michael Moretti KLINGER MEDICAL 27812 RUISENOR Mission Viejo, CA 92691 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-22 |
| Decision Date | 1990-06-26 |