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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Coagulation
510(k) Number K862047
Device Name COAGULATOR (8 CHANNEL)
Applicant
Med USA
23 Bradford St.
W. Concord,  MA  01742
Applicant Contact ISMAIL NABIH
Correspondent
Med USA
23 Bradford St.
W. Concord,  MA  01742
Correspondent Contact ISMAIL NABIH
Regulation Number864.5400
Classification Product Code
KQG  
Date Received05/29/1986
Decision Date 09/29/1986
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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