The following data is part of a premarket notification filed by Martin Uram, Md with the FDA for E3 Microprob Series Of Lasers And Accessories.
Device ID | K000192 |
510k Number | K000192 |
Device Name: | E3 MICROPROB SERIES OF LASERS AND ACCESSORIES |
Classification | Powered Laser Surgical Instrument |
Applicant | MARTIN URAM, MD 39 SYCAMORE AVE. Little Silver, NJ 07739 -1208 |
Contact | Martin Uram |
Correspondent | Martin Uram MARTIN URAM, MD 39 SYCAMORE AVE. Little Silver, NJ 07739 -1208 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-01-20 |
Decision Date | 2000-04-10 |