The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Resistick Solid Laparoscopic Electrodes.
Device ID | K971621 |
510k Number | K971621 |
Device Name: | RESISTICK SOLID LAPAROSCOPIC ELECTRODES |
Classification | Coagulator-cutter, Endoscopic, Unipolar (and 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 | KNF |
CFR Regulation Number | 884.4160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-05-01 |
Decision Date | 1997-06-20 |