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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Instrument, Microsurgical
510(k) Number K862971
Device Name MICRA MICROSURGICAL INSTRUMENTS
Applicant
Cordis Corp.
P.O. Box 025700
Miami,  FL  33102
Applicant Contact HENNEMANN, PHD
Correspondent
Cordis Corp.
P.O. Box 025700
Miami,  FL  33102
Correspondent Contact HENNEMANN, PHD
Regulation Number882.4525
Classification Product Code
GZX  
Date Received08/06/1986
Decision Date 08/25/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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