The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Model #27224p Continuous Flow Pump.
| Device ID | K832009 |
| 510k Number | K832009 |
| Device Name: | MODEL #27224P CONTINUOUS FLOW PUMP |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-23 |
| Decision Date | 1983-07-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551366837 | K832009 | 000 |