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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K920949
Device Name SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5
Applicant
Heraeus Kulzer, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact THOMAS C BREWSTER
Correspondent
Heraeus Kulzer, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact THOMAS C BREWSTER
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received03/02/1992
Decision Date 05/15/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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