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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 K001966
Device Name REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND
Applicant
Micro Therapeutics, Inc.
2 Goodyear
Irvine,  CA  92618
Applicant Contact MARIBELLE AGUINALDO
Correspondent
Micro Therapeutics, Inc.
2 Goodyear
Irvine,  CA  92618
Correspondent Contact MARIBELLE AGUINALDO
Regulation Number870.1210
Classification Product Code
KRA  
Date Received06/28/2000
Decision Date 07/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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