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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Automated Sedimentation Rate
510(k) Number K890503
Device Name SR30/SR50/SR60 AUTOMATED SEDIMENTATION RATE
Applicant
Gespac, Inc.
50 W. Hoover Ave.
Mesa,  AZ  85210
Applicant Contact COSMA PABOUCTSIDIS
Correspondent
Gespac, Inc.
50 W. Hoover Ave.
Mesa,  AZ  85210
Correspondent Contact COSMA PABOUCTSIDIS
Regulation Number864.5800
Classification Product Code
GKB  
Date Received02/01/1989
Decision Date 02/10/1989
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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