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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 K951256
Device Name DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)
Applicant
TARGET THERAPEUTICS
47201 LAKEVIEW BLVD.
P.O. BOX 5120
FREEMONT,  CA  94538
Applicant Contact LARAINE PANGELINA
Correspondent
TARGET THERAPEUTICS
47201 LAKEVIEW BLVD.
P.O. BOX 5120
FREEMONT,  CA  94538
Correspondent Contact LARAINE PANGELINA
Regulation Number882.5950
Classification Product Code
HCG  
Date Received03/21/1995
Decision Date 09/08/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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