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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K931900
Device Name COMPUTER ASSISTED ARCHIVAL TECH. PHYSIOLOGY STAT.
Applicant
Archival Technologies, Inc.
809 C. S. Orlando Ave.
Winter Park,  FL  32789
Applicant Contact JEFFREY M DYBDAHL
Correspondent
Archival Technologies, Inc.
809 C. S. Orlando Ave.
Winter Park,  FL  32789
Correspondent Contact JEFFREY M DYBDAHL
Regulation Number870.1425
Classification Product Code
DQK  
Date Received04/19/1993
Decision Date 03/11/1994
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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