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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 K954726
Device Name STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)
Applicant
Stryker Endoscopy
2590 WALSH AVE.
SANTA CLARA,  CA  95051 -4085
Applicant Contact CHARLES L NELSON
Correspondent
Stryker Endoscopy
2590 WALSH AVE.
SANTA CLARA,  CA  95051 -4085
Correspondent Contact CHARLES L NELSON
Regulation Number880.6740
Classification Product Code
GCX  
Date Received08/03/1995
Decision Date 11/29/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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