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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K854941
Device Name PMS PERCUTANEOUS PUNCTURE NEEDLE
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 Number870.1340
Classification Product Code
DYB  
Date Received12/10/1985
Decision Date 04/16/1986
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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