The following data is part of a premarket notification filed by Gm Engineering, Inc. with the FDA for Continuous Flow Biopsy Probe.
Device ID | K942626 |
510k Number | K942626 |
Device Name: | CONTINUOUS FLOW BIOPSY PROBE |
Classification | Resectoscope, Working Element |
Applicant | GM ENGINEERING, INC. 2549 SIERRA WAY, SUITE B La Verne, CA 91750 |
Contact | David C Steffin |
Correspondent | David C Steffin GM ENGINEERING, INC. 2549 SIERRA WAY, SUITE B La Verne, CA 91750 |
Product Code | FDC |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-02 |
Decision Date | 1995-05-30 |