The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Cassette Pump.
| Device ID | K042454 |
| 510k Number | K042454 |
| Device Name: | STRYKER CASSETTE PUMP |
| Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Applicant | Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Contact | Christopher L Cook |
| Correspondent | Christopher L Cook Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Product Code | GCX |
| Subsequent Product Code | HET |
| Subsequent Product Code | KQT |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-10 |
| Decision Date | 2004-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37613327061476 | K042454 | 000 |
| 07613327052138 | K042454 | 000 |