The following data is part of a premarket notification filed by Klinger Micro-controle Group with the FDA for Model Mc 1100 Surgical Yag Laser.
Device ID | K903943 |
510k Number | K903943 |
Device Name: | MODEL MC 1100 SURGICAL YAG LASER |
Classification | Powered Laser Surgical Instrument |
Applicant | KLINGER MICRO-CONTROLE GROUP 272812 RUISENOR Mission Viejo, CA 92691 |
Contact | Michael Moretti |
Correspondent | Michael Moretti KLINGER MICRO-CONTROLE GROUP 272812 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 | 1990-08-27 |
Decision Date | 1990-11-21 |