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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Pressure, Catheter Tip
510(k) Number K093111
Device Name MIKRO-CATH, MODEL 825-0101
Applicant
Millar Instruments, Inc.
6001-A Gulf Freeway
Houston,  TX  77023 -5417
Applicant Contact FATMA ALI
Correspondent
Millar Instruments, Inc.
6001-A Gulf Freeway
Houston,  TX  77023 -5417
Correspondent Contact FATMA ALI
Regulation Number870.2870
Classification Product Code
DXO  
Date Received10/01/2009
Decision Date 01/05/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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