The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Electrosurgical Elecrtrodes.
Device ID | K962271 |
510k Number | K962271 |
Device Name: | ELECTROSURGICAL ELECRTRODES |
Classification | Hysteroscope (and Accessories) |
Applicant | NORTHGATE TECHNOLOGIES, INC. 600 CHURCH RD. Elgin, IL 60123 |
Contact | Casey Kurek |
Correspondent | Casey Kurek NORTHGATE TECHNOLOGIES, INC. 600 CHURCH RD. Elgin, IL 60123 |
Product Code | HIH |
CFR Regulation Number | 884.1690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-13 |
Decision Date | 1997-08-08 |
Summary: | summary |