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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name shunt, central nervous system and components
510(k) Number K883114
Device Name SPETZLER MANKIND VENTRICULOSTOMY EXTERNAL 1114-1
Applicant
PMT CORP.
1500 PARK RD.
CHANHASSEN,  MN  55317
Applicant Contact ALFRED IVERSEN
Correspondent
PMT CORP.
1500 PARK RD.
CHANHASSEN,  MN  55317
Correspondent Contact ALFRED IVERSEN
Regulation Number882.5550
Classification Product Code
JXG  
Date Received07/25/1988
Decision Date 08/24/1988
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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