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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 K881616
Device Name PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1
Applicant
PROGRESS MANKIND TECHNOLOGY
BOX 484
CHANHASSEN,  MN  55317
Applicant Contact ALFRED A IVERSEN
Correspondent
PROGRESS MANKIND TECHNOLOGY
BOX 484
CHANHASSEN,  MN  55317
Correspondent Contact ALFRED A IVERSEN
Regulation Number882.5550
Classification Product Code
JXG  
Date Received04/12/1988
Decision Date 09/09/1988
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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