The following data is part of a premarket notification filed by Rita Medical Systems with the FDA for Rita Model 70 Electrosurgical Probe.
Device ID | K983871 |
510k Number | K983871 |
Device Name: | RITA MODEL 70 ELECTROSURGICAL PROBE |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | RITA MEDICAL SYSTEMS 967 NORTH SHORELINE BLVD. Mountain View, CA 94043 |
Contact | David A Tucker |
Correspondent | David A Tucker RITA MEDICAL SYSTEMS 967 NORTH SHORELINE BLVD. Mountain View, CA 94043 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-11-02 |
Decision Date | 1998-12-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H7877001014931 | K983871 | 000 |
H7877001014921 | K983871 | 000 |
H7877001023311 | K983871 | 000 |
H7877001023300 | K983871 | 000 |