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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dispenser, Liquid Medication
510(k) Number K954181
Device Name CANYONS BI-DIRECTIONAL CHECK VALVE
Applicant
Canyon Medical Products
2850 E. 7320 S.
Salt Lake City,  UT  84121
Applicant Contact STEVEN M SMITH
Correspondent
Canyon Medical Products
2850 E. 7320 S.
Salt Lake City,  UT  84121
Correspondent Contact STEVEN M SMITH
Regulation Number880.6430
Classification Product Code
KYX  
Date Received09/06/1995
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
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