The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Endoscopic Video Accessories.
Device ID | K935234 |
510k Number | K935234 |
Device Name: | STRYKER ENDOSCOPIC VIDEO ACCESSORIES |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | Stryker Endoscopy 210 BAYPOINTE PKWY. San Jose, CA 95134 |
Contact | Thomas Kelly |
Correspondent | Thomas Kelly Stryker Endoscopy 210 BAYPOINTE PKWY. San Jose, CA 95134 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-11-01 |
Decision Date | 1994-03-18 |