The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for 3-chip Video Camera.
Device ID | K983566 |
510k Number | K983566 |
Device Name: | 3-CHIP VIDEO CAMERA |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
Contact | Rick Beutter |
Correspondent | Rick Beutter Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-10-13 |
Decision Date | 1999-01-11 |
Summary: | summary |