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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Operating-Room, Wall Vacuum Powered
510(k) Number K042454
Device Name STRYKER CASSETTE PUMP
Applicant
Stryker Endoscopy
5900 OPTICAL CT.
SAN JOSE,  CA  95138
Applicant Contact CHRISTOPHER L COOK
Correspondent
Stryker Endoscopy
5900 OPTICAL CT.
SAN JOSE,  CA  95138
Correspondent Contact CHRISTOPHER L COOK
Regulation Number880.6740
Classification Product Code
GCX  
Subsequent Product Codes
HET   KQT  
Date Received09/10/2004
Decision Date 12/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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