The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Endomat Lc Pump, Model 20 3303 20.
| Device ID | K031457 |
| 510k Number | K031457 |
| Device Name: | ENDOMAT LC PUMP, MODEL 20 3303 20 |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Paul S Lee |
| Correspondent | Paul S Lee KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-08 |
| Decision Date | 2004-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551067642 | K031457 | 000 |
| 04048551064597 | K031457 | 000 |
| 04048551064467 | K031457 | 000 |