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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K993672
Device Name REBAR MICRO CATHETER, MODELS 105-5080, 105-5086
Applicant
Micro Therapeutics, Inc.
2 Goodyear
Irvine,  CA  92618
Applicant Contact TOM DAUGHTERS
Correspondent
Micro Therapeutics, Inc.
2 Goodyear
Irvine,  CA  92618
Correspondent Contact TOM DAUGHTERS
Regulation Number870.1210
Classification Product Code
KRA  
Date Received11/01/1999
Decision Date 01/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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