The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Davol Electro Medical Systems.
Device ID | K810273 |
510k Number | K810273 |
Device Name: | DAVOL ELECTRO MEDICAL SYSTEMS |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | C.R. BARD, INC. 110 MARSHALL DRIVE Warrandale, PA 15086 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-02-02 |
Decision Date | 1981-03-04 |