The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Device, Electrosurgical, Cutting And Coagulation & Accessories.
Device ID | K950406 |
510k Number | K950406 |
Device Name: | DEVICE, ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIES |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 |
Contact | J R Saron |
Correspondent | J R Saron AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-01-31 |
Decision Date | 1995-04-13 |