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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator For Hemoglobin And Hematocrit Measurement
510(k) Number K883703
Device Name MSI-CAL 7
Applicant
Medical Specialties, Inc.
3610 Kennedy Rd.
South Plainfield,  NJ  07080
Applicant Contact RON DEVITA
Correspondent
Medical Specialties, Inc.
3610 Kennedy Rd.
South Plainfield,  NJ  07080
Correspondent Contact RON DEVITA
Regulation Number864.8165
Classification Product Code
KRZ  
Date Received08/30/1988
Decision Date 11/22/1988
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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