The following data is part of a premarket notification filed by Optical Micro Systems, Inc. with the FDA for Aspiration Reversal Control (arc) Module.
Device ID | K870068 |
510k Number | K870068 |
Device Name: | ASPIRATION REVERSAL CONTROL (ARC) MODULE |
Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
Applicant | OPTICAL MICRO SYSTEMS, INC. 8 ELECTRONICS AVE. Danvers, MA 01923 |
Contact | Gerald Clay |
Correspondent | Gerald Clay OPTICAL MICRO SYSTEMS, INC. 8 ELECTRONICS AVE. Danvers, MA 01923 |
Product Code | HQE |
CFR Regulation Number | 886.4150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-08 |
Decision Date | 1987-02-12 |