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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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