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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K053311
Device Name STRYKER SCOPE WARMER
Applicant
Stryker Endoscopy
5900 OPTICAL CT.
SAN JOSE,  CA  95138
Applicant Contact CRYSTAL ONG
Correspondent
Stryker Endoscopy
5900 OPTICAL CT.
SAN JOSE,  CA  95138
Correspondent Contact CRYSTAL ONG
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/28/2005
Decision Date 01/27/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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