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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Cell, Automated (Particle Counter)
510(k) Number K853429
Device Name COULTER COUNTER MODEL M5
Applicant
COULTER ELECTRONICS, INC.
440 WEST 20 ST.
HIALEAH,  FL  33010
Applicant Contact RICHARDSON-JONES
Correspondent
COULTER ELECTRONICS, INC.
440 WEST 20 ST.
HIALEAH,  FL  33010
Correspondent Contact RICHARDSON-JONES
Regulation Number864.5200
Classification Product Code
GKL  
Date Received08/15/1985
Decision Date 10/10/1985
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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