The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Scope/instrument Holder.
Device ID | K060085 |
510k Number | K060085 |
Device Name: | STRYKER SCOPE/INSTRUMENT HOLDER |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
Contact | Crystal Ong |
Correspondent | Crystal Ong Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-01-11 |
Decision Date | 2006-04-27 |
Summary: | summary |