The following data is part of a premarket notification filed by Martin Uram, Md with the FDA for E3 Microprobe.
Device ID | K974878 |
510k Number | K974878 |
Device Name: | E3 MICROPROBE |
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 | 1997-12-30 |
Decision Date | 1998-03-27 |
Summary: | summary |