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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 K962988
Device Name COULTER GEN-S SYSTEM
Applicant
Coulter Corp.
11800 SW 147th Ave.
Mail Code 31-B06
Miami,  FL  33196 -2500
Applicant Contact THOMAS J ENGLISH
Correspondent
Coulter Corp.
11800 SW 147th Ave.
Mail Code 31-B06
Miami,  FL  33196 -2500
Correspondent Contact THOMAS J ENGLISH
Regulation Number864.5200
Classification Product Code
GKL  
Subsequent Product Code
GKJ  
Date Received08/01/1996
Decision Date 10/30/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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