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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Pca
510(k) Number K920637
Device Name PRIME PCA AND PCA/CONTINUOUS SYSTEMS
Applicant
Prime Medical Products, Inc.
12472 Park Ave.
Windermere,  FL  34786
Applicant Contact BRIAN D ZDEB
Correspondent
Prime Medical Products, Inc.
12472 Park Ave.
Windermere,  FL  34786
Correspondent Contact BRIAN D ZDEB
Regulation Number880.5725
Classification Product Code
MEA  
Date Received02/12/1992
Decision Date 01/15/1993
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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