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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 K871830
Device Name NAPSAC(TM)
Applicant
Beecher Medical Diagnostic Instrumentation
9007 Woodland Dr.
Silver Spring,  MD  20910
Applicant Contact STEPHEN LEIGHTON,DSC
Correspondent
Beecher Medical Diagnostic Instrumentation
9007 Woodland Dr.
Silver Spring,  MD  20910
Correspondent Contact STEPHEN LEIGHTON,DSC
Regulation Number864.5200
Classification Product Code
GKL  
Date Received05/11/1987
Decision Date 09/09/1987
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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