The following data is part of a premarket notification filed by Modern Medical Equipment Mfg., Ltd. with the FDA for Non-stick Electrode.
Device ID | K043036 |
510k Number | K043036 |
Device Name: | NON-STICK ELECTRODE |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | MODERN MEDICAL EQUIPMENT MFG., LTD. 1705 DABNEY ROAD Richmond, VA 23230 |
Contact | Robert Stillman |
Correspondent | Robert Stillman MODERN MEDICAL EQUIPMENT MFG., LTD. 1705 DABNEY ROAD Richmond, VA 23230 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-11-04 |
Decision Date | 2005-05-06 |
Summary: | summary |