The following data is part of a premarket notification filed by Optical Micro Systems, Inc. with the FDA for Electric I/v Pole Or Eivp2.
Device ID | K935003 |
510k Number | K935003 |
Device Name: | ELECTRIC I/V POLE OR EIVP2 |
Classification | Device, Irrigation, Ocular Surgery |
Applicant | OPTICAL MICRO SYSTEMS, INC. 300 WILLOW ST. SOUTH North Andover, MA 01845 |
Contact | Ronald Luich |
Correspondent | Ronald Luich OPTICAL MICRO SYSTEMS, INC. 300 WILLOW ST. SOUTH North Andover, MA 01845 |
Product Code | KYG |
CFR Regulation Number | 886.4360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-10-19 |
Decision Date | 1994-01-25 |