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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 K882286
Device Name EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SET
Applicant
METATECH CORP.
420 NORTHGATE PKWY.
WHEELING,  IL  60090
Applicant Contact DAVID W WILSON
Correspondent
METATECH CORP.
420 NORTHGATE PKWY.
WHEELING,  IL  60090
Correspondent Contact DAVID W WILSON
Regulation Number882.1620
Classification Product Code
GWM  
Date Received06/01/1988
Decision Date 07/18/1988
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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