The following data is part of a premarket notification filed by Modern Medical Equipment Mfg., Ltd. with the FDA for Endocervical Electrode # 2.
Device ID | K070877 |
510k Number | K070877 |
Device Name: | ENDOCERVICAL ELECTRODE # 2 |
Classification | Electrocautery, Gynecologic (and Accessories) |
Applicant | MODERN MEDICAL EQUIPMENT MFG., LTD. 1705 DABNEY ROAD Richmond, VA 23230 |
Contact | Bob Stillman |
Correspondent | Bob Stillman MODERN MEDICAL EQUIPMENT MFG., LTD. 1705 DABNEY ROAD Richmond, VA 23230 |
Product Code | HGI |
CFR Regulation Number | 884.4120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-03-29 |
Decision Date | 2007-07-27 |
Summary: | summary |