The following data is part of a premarket notification filed by Optical Micro Systems, Inc. with the FDA for Emergency Power Pac (empac).
Device ID | K813273 |
510k Number | K813273 |
Device Name: | EMERGENCY POWER PAC (EMPAC) |
Classification | Instrument, Vitreous Aspiration And Cutting, Battery-powered |
Applicant | OPTICAL MICRO SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HKP |
CFR Regulation Number | 886.4150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-11-20 |
Decision Date | 1981-12-31 |