The following data is part of a premarket notification filed by Mira, Inc. with the FDA for Power Operated And Controlled Vitreous Scissors.
Device ID | K891601 |
510k Number | K891601 |
Device Name: | POWER OPERATED AND CONTROLLED VITREOUS SCISSORS |
Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
Applicant | MIRA, INC. 87 RUMFORD AVE. Waltham, MA 02453 -3846 |
Contact | R O'brien |
Correspondent | R O'brien MIRA, INC. 87 RUMFORD AVE. Waltham, MA 02453 -3846 |
Product Code | HQE |
CFR Regulation Number | 886.4150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-20 |
Decision Date | 1989-05-23 |