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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K952773
Device Name MIKRO-TIP ANGIOGRAPHIC CATHETER
Applicant
Millar Instruments, Inc.
6001 Gulf Freeway, #534-G
Houston,  TX  77023 -5417
Applicant Contact JEFF KASOFF
Correspondent
Millar Instruments, Inc.
6001 Gulf Freeway, #534-G
Houston,  TX  77023 -5417
Correspondent Contact JEFF KASOFF
Regulation Number870.1200
Classification Product Code
DQO  
Date Received06/16/1995
Decision Date 11/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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