The following data is part of a premarket notification filed by Oratec Interventions, Inc. with the FDA for Oratec Interventions Vulcan Eas Electrothermal Arthroscopy System And Accessories.
Device ID | K991140 |
510k Number | K991140 |
Device Name: | ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND ACCESSORIES |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | ORATEC INTERVENTIONS, INC. 3700 HAVEN CT. Menlo Park, CA 94025 |
Contact | Sheila Ramerman |
Correspondent | Sheila Ramerman ORATEC INTERVENTIONS, INC. 3700 HAVEN CT. Menlo Park, CA 94025 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-04-05 |
Decision Date | 1999-10-25 |
Summary: | summary |