The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Aaron Reusable Electrosurgical Electrode.
Device ID | K014201 |
510k Number | K014201 |
Device Name: | AARON REUSABLE ELECTROSURGICAL ELECTRODE |
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 | 2001-12-21 |
Decision Date | 2002-02-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00607151018115 | K014201 | 000 |
00607151002442 | K014201 | 000 |
00607151002435 | K014201 | 000 |
00607151002428 | K014201 | 000 |
00607151002411 | K014201 | 000 |
00607151002404 | K014201 | 000 |
00607151002398 | K014201 | 000 |
00607151002381 | K014201 | 000 |
00607151002374 | K014201 | 000 |
00607151002459 | K014201 | 000 |
00607151002466 | K014201 | 000 |
00607151002473 | K014201 | 000 |
00607151003180 | K014201 | 000 |
00607151002541 | K014201 | 000 |
00607151002534 | K014201 | 000 |
00607151002527 | K014201 | 000 |
00607151002510 | K014201 | 000 |
00607151002503 | K014201 | 000 |
00607151002497 | K014201 | 000 |
00607151002480 | K014201 | 000 |
00607151002367 | K014201 | 000 |