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 |