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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, monitoring, intracranial pressure
510(k) Number K896834
Device Name MODEL BT-1 FOT BOLT INSTALLATION KIT
Applicant
PEARL INSTRUMENTS CORP.
3382 DATO AVE.
HIGHLAND PARK,  IL  60035
Applicant Contact ALFRED R PERLIN,PHD
Correspondent
PEARL INSTRUMENTS CORP.
3382 DATO AVE.
HIGHLAND PARK,  IL  60035
Correspondent Contact ALFRED R PERLIN,PHD
Regulation Number882.1620
Classification Product Code
GWM  
Date Received12/05/1989
Decision Date 02/23/1990
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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