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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 Cell-Locating
510(k) Number K925670
Device Name IMS-200
Applicant
Intelligent Medica Imaging, Inc.
4360 Northlake Blvd.,
Suite 108
Palm Beach Gardens,  FL  33410
Applicant Contact TYCE FITZMORRIS
Correspondent
Intelligent Medica Imaging, Inc.
4360 Northlake Blvd.,
Suite 108
Palm Beach Gardens,  FL  33410
Correspondent Contact TYCE FITZMORRIS
Regulation Number864.5260
Classification Product Code
JOY  
Date Received11/10/1992
Decision Date 07/23/1993
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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