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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixer, Blood Tube
510(k) Number K823124
Device Name IMS HEMATOLOGY MIXER
Applicant
Innovative Medical Systems, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Innovative Medical Systems, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2050
Classification Product Code
GLE  
Date Received10/22/1982
Decision Date 11/22/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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