STRYKER SCOPE WARMER

Laparoscope, General & Plastic Surgery

Stryker Endoscopy

The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Scope Warmer.

Pre-market Notification Details

Device IDK053311
510k NumberK053311
Device Name:STRYKER SCOPE WARMER
ClassificationLaparoscope, General & Plastic Surgery
Applicant Stryker Endoscopy 5900 OPTICAL CT. San Jose,  CA  95138
ContactCrystal Ong
CorrespondentCrystal Ong
Stryker Endoscopy 5900 OPTICAL CT. San Jose,  CA  95138
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-11-28
Decision Date2006-01-27
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.