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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Neurovascular Embolization
510(k) Number K925876
Device Name ITC BUNJI PLATINUM EMBOLIZATION COIL
Applicant
Interventional Therapeutics Corp.
385 Oyster Point Blvd.
Suite 6
South San Francisco,  CA  94080
Applicant Contact LUANNE TERMEER
Correspondent
Interventional Therapeutics Corp.
385 Oyster Point Blvd.
Suite 6
South San Francisco,  CA  94080
Correspondent Contact LUANNE TERMEER
Regulation Number882.5950
Classification Product Code
HCG  
Date Received11/19/1992
Decision Date 04/15/1993
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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