The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Aaron A950 High Frequency Electrosurgical Generator, Aaron A950 Electrosurgical Generator, 240v.
Device ID | K021817 |
510k Number | K021817 |
Device Name: | AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950 ELECTROSURGICAL GENERATOR, 240V |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 -2902 |
Contact | Richard A Kozloff |
Correspondent | Richard A Kozloff 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 | 2002-06-03 |
Decision Date | 2002-07-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00192896009202 | K021817 | 000 |
00192896009196 | K021817 | 000 |
00192896009189 | K021817 | 000 |
20612479212927 | K021817 | 000 |
00887482176894 | K021817 | 000 |