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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 K871853
Device Name V-MARC 88A COMPUTER
Applicant
V.Marc, A Div. of Pictorial, Inc.
8081 Zionsville Rd.
Box 68886
Indianapolis,  IN  46268
Applicant Contact WILLIAM R PIPPIN
Correspondent
V.Marc, A Div. of Pictorial, Inc.
8081 Zionsville Rd.
Box 68886
Indianapolis,  IN  46268
Correspondent Contact WILLIAM R PIPPIN
Regulation Number862.2100
Classification Product Code
JQP  
Date Received05/12/1987
Decision Date 07/16/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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