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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 K852492
Device Name COAGULATOR
Applicant
Med USA
319 Waverley Oaks Rd.
Waltham,  MA  02154
Applicant Contact ISMAIL NABIH
Correspondent
Med USA
319 Waverley Oaks Rd.
Waltham,  MA  02154
Correspondent Contact ISMAIL NABIH
Regulation Number864.5400
Classification Product Code
KQG  
Date Received06/12/1985
Decision Date 08/13/1985
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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