The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Arthroscope.
Device ID | K093677 |
510k Number | K093677 |
Device Name: | STRYKER ARTHROSCOPE |
Classification | Arthroscope |
Applicant | Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
Contact | Shibir Desai |
Correspondent | Shibir Desai Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-11-27 |
Decision Date | 2010-03-05 |
Summary: | summary |