The following data is part of a premarket notification filed by Patton Medical Corp. with the FDA for Patton Tripol.
Device ID | K012279 |
510k Number | K012279 |
Device Name: | PATTON TRIPOL |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | PATTON MEDICAL CORP. 1000 WESTBANK DR. SUITE 5A200 Austin, TX 78746 |
Contact | Michael T Patton |
Correspondent | Michael T Patton PATTON MEDICAL CORP. 1000 WESTBANK DR. SUITE 5A200 Austin, TX 78746 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-07-19 |
Decision Date | 2002-04-30 |
Summary: | summary |