The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Fluid Pump, Cp #3.
| Device ID | K914524 |
| 510k Number | K914524 |
| Device Name: | FLUID PUMP, CP #3 |
| Classification | Accessories, Cleaning, For Endoscope |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 7123 INDUSTRIAL PARK BLVD. Mentor, OH 44060 |
| Contact | Lisa M Scholz |
| Correspondent | Lisa M Scholz UNITED STATES ENDOSCOPY GROUP, INC. 7123 INDUSTRIAL PARK BLVD. Mentor, OH 44060 |
| Product Code | FEB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-10 |
| Decision Date | 1994-03-09 |