The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Hip Arthoroscopy Set.
Device ID | K982375 |
510k Number | K982375 |
Device Name: | STRYKER HIP ARTHOROSCOPY SET |
Classification | Arthroscope |
Applicant | Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
Contact | Baltazar Acousta |
Correspondent | Baltazar Acousta 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 | 1998-07-07 |
Decision Date | 1998-10-02 |
Summary: | summary |