The following data is part of a premarket notification filed by Spectracare, Inc. with the FDA for Dwyer Eye Systems Aspiration Unit.
Device ID | K913261 |
510k Number | K913261 |
Device Name: | DWYER EYE SYSTEMS ASPIRATION UNIT |
Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
Applicant | SPECTRACARE, INC. C/O MEDICAL DEVICE CONSULTANTS 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
Contact | Lynne Aronson |
Correspondent | Lynne Aronson SPECTRACARE, INC. C/O MEDICAL DEVICE CONSULTANTS 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
Product Code | HQE |
CFR Regulation Number | 886.4150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-23 |
Decision Date | 1992-01-30 |