The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Tempest Orthopedic Pump.
| Device ID | K963304 |
| 510k Number | K963304 |
| Device Name: | STRYKER TEMPEST ORTHOPEDIC PUMP |
| Classification | Arthroscope |
| Applicant | Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Contact | Roy S Chin |
| Correspondent | Roy S Chin Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-22 |
| Decision Date | 1997-01-22 |
| Summary: | summary |