The following data is part of a premarket notification filed by Northgate Research, Inc. with the FDA for 2.5 French Lithotriptor Electrode.
Device ID | K894704 |
510k Number | K894704 |
Device Name: | 2.5 FRENCH LITHOTRIPTOR ELECTRODE |
Classification | Lithotriptor, Electro-hydraulic |
Applicant | NORTHGATE RESEARCH, INC. 3930 VENTURA DR. SUITE 400 Arlington Heights, IL 60004 |
Contact | D Emrich |
Correspondent | D Emrich NORTHGATE RESEARCH, INC. 3930 VENTURA DR. SUITE 400 Arlington Heights, IL 60004 |
Product Code | FFK |
CFR Regulation Number | 876.4480 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-07-25 |
Decision Date | 1989-10-18 |