The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Aaron Vac 2.
Device ID | K952558 |
510k Number | K952558 |
Device Name: | AARON VAC 2 |
Classification | Instrument, Vitreous Aspiration And Cutting, Battery-powered |
Applicant | AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 |
Contact | J. Robert Saron |
Correspondent | J. Robert Saron AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 |
Product Code | HKP |
CFR Regulation Number | 886.4150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-02 |
Decision Date | 1997-03-19 |