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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name drills, burrs, trephines & accessories (compound, powered)
510(k) Number K982991
Device Name ANSPACH ACCESS CRANIAL PERFORATOR
Applicant
THE ANSPACH EFFORT, INC.
4500 RIVERSIDE DR.
PALM BEACH GARDENS,  FL  33410
Applicant Contact LISA KREIDER
Correspondent
THE ANSPACH EFFORT, INC.
4500 RIVERSIDE DR.
PALM BEACH GARDENS,  FL  33410
Correspondent Contact LISA KREIDER
Regulation Number882.4305
Classification Product Code
HBF  
Date Received08/27/1998
Decision Date 10/21/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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