The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Irrigation Tube Set.
| Device ID | K000493 |
| 510k Number | K000493 |
| Device Name: | STRYKER IRRIGATION TUBE SET |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Contact | Mark Kuiper |
| Correspondent | Mark Kuiper Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-15 |
| Decision Date | 2000-05-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37613327061667 | K000493 | 000 |
| 37613327061643 | K000493 | 000 |