The following data is part of a premarket notification filed by Stryker with the FDA for Precision Ideal Eyes Arthroscopes.
Device ID | K183470 |
510k Number | K183470 |
Device Name: | Precision Ideal Eyes Arthroscopes |
Classification | Arthroscope |
Applicant | Stryker 5900 Optical Court San Jose, CA 95138 |
Contact | Jessie Duong |
Correspondent | Jessie Duong Stryker 5900 Optical Court San Jose, CA 95138 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-12-14 |
Decision Date | 2019-01-07 |
Summary: | summary |