The following data is part of a premarket notification filed by Keymed, Inc. with the FDA for Olympus Flushing Pump Ofp Model: Ofp-1.
| Device ID | K100803 |
| 510k Number | K100803 |
| Device Name: | OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 |
| Classification | Pump, Air, Non-manual, For Endoscope |
| Applicant | KEYMED, INC. 11440 W. BERNARDO DRIVE SUITE 300 San Diego, CA 92127 |
| Contact | Ronald Warren |
| Correspondent | Ronald Warren KEYMED, INC. 11440 W. BERNARDO DRIVE SUITE 300 San Diego, CA 92127 |
| Product Code | FEQ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-22 |
| Decision Date | 2010-04-22 |
| Summary: | summary |