The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Crossflow Arthroscopy Pump.
Device ID | K123441 |
510k Number | K123441 |
Device Name: | STRYKER CROSSFLOW ARTHROSCOPY PUMP |
Classification | Arthroscope |
Applicant | Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
Contact | Kevin Potgieter |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2012-11-08 |
Decision Date | 2013-01-09 |
Summary: | summary |