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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 K920324
Device Name ITC BUNJI COIL (MODIFICATION)
Applicant
INTERVENTIONAL THERAPEUTICS CORP.
385 OYSTER POINT BLVD.
SUITE 6
SOUTH SAN FRANCISCO,  CA  94080
Applicant Contact JULIE D BELL
Correspondent
INTERVENTIONAL THERAPEUTICS CORP.
385 OYSTER POINT BLVD.
SUITE 6
SOUTH SAN FRANCISCO,  CA  94080
Correspondent Contact JULIE D BELL
Regulation Number882.5950
Classification Product Code
HCG  
Date Received01/24/1992
Decision Date 07/29/1992
Decision SE - Postmarket Surveillance Required (SESP)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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