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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator/Data Processing Module, For Clinical Use
510(k) Number K953652
Device Name PRENVAL I
Applicant
Base Ten Systems, Inc.
One Electtonics Dr.
P.O. Box 3151
Trenton,  NJ  08619
Applicant Contact RICHARD J FARRELLY
Correspondent
Base Ten Systems, Inc.
One Electtonics Dr.
P.O. Box 3151
Trenton,  NJ  08619
Correspondent Contact RICHARD J FARRELLY
Regulation Number862.2100
Classification Product Code
JQP  
Date Received08/07/1995
Decision Date 09/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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