The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Aaron Esu Foot-control Adapter #a1205a.
Device ID | K984236 |
510k Number | K984236 |
Device Name: | AARON ESU FOOT-CONTROL ADAPTER #A1205A |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 -2902 |
Contact | J. Robert Saron |
Correspondent | J. Robert Saron AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 -2902 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-11-25 |
Decision Date | 1999-02-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00607151001575 | K984236 | 000 |