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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Impedance
510(k) Number K860749
Device Name HA-2 HUMAN BODY COMPOSITION ANALYZER
Applicant
Dj Medical Instrument Corp. C/O Keller & Heckman
1150 17th St., NW
Suite 1000
Washington,  DC  20036
Applicant Contact JOHN B DUBECK
Correspondent
Dj Medical Instrument Corp. C/O Keller & Heckman
1150 17th St., NW
Suite 1000
Washington,  DC  20036
Correspondent Contact JOHN B DUBECK
Regulation Number870.2770
Classification Product Code
DSB  
Date Received02/27/1986
Decision Date 09/02/1986
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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