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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Timer, Clot, Automated
510(k) Number K913320
Device Name MIL CM-II COAGULATION MACHINE
Applicant
Medical Innovations Corp.
13-B, Edward Mansion
141 Prince Edward Rd.
Kowloon, Hong Kong,  HK
Applicant Contact RAYMOND CHAN
Correspondent
Medical Innovations Corp.
13-B, Edward Mansion
141 Prince Edward Rd.
Kowloon, Hong Kong,  HK
Correspondent Contact RAYMOND CHAN
Regulation Number864.5400
Classification Product Code
GKN  
Date Received07/25/1991
Decision Date 06/16/1992
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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