The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Videoscope.
Device ID | K082451 |
510k Number | K082451 |
Device Name: | STRYKER VIDEOSCOPE |
Classification | Laparoscope, Gynecologic (and Accessories) |
Applicant | Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
Contact | Desiree Crisolo |
Correspondent | Desiree Crisolo Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
Product Code | HET |
CFR Regulation Number | 884.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-08-25 |
Decision Date | 2008-12-16 |
Summary: | summary |