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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K913094
Device Name DISPOSABLE SLIDE VALVE MANIFOLD
Applicant
Professional Medical Services
P.O. Box 250
700 W. 200 N.
North Salt Lake,  UT  84054
Applicant Contact JAMES E WILLIAMS
Correspondent
Professional Medical Services
P.O. Box 250
700 W. 200 N.
North Salt Lake,  UT  84054
Correspondent Contact JAMES E WILLIAMS
Regulation Number870.1200
Classification Product Code
DQO  
Date Received07/12/1991
Decision Date 01/27/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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