The following data is part of a premarket notification filed by Keymed (medical & Industrial Equipment), Ltd. with the FDA for Olympus Endoscopic Flushing Pump, Model Opf-2.
Device ID | K100899 |
510k Number | K100899 |
Device Name: | OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 |
Classification | Pump, Air, Non-manual, For Endoscope |
Applicant | KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. 11440 WEST BERNARDO DRIVE SUITE 300 San Diego, CA 92127 |
Contact | Ron Warren |
Correspondent | Ron Warren KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. 11440 WEST BERNARDO DRIVE SUITE 300 San Diego, CA 92127 |
Product Code | FEQ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-03-31 |
Decision Date | 2010-09-13 |
Summary: | summary |