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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name motor, drill, electric
510(k) Number K133604
Device Name ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS
Applicant
THE ANSPACH EFFORT, INC.
4500 RIVERSIDE DR.
PALM BEACH GARDENS,  FL  33410
Applicant Contact JEANNETTE G DAILEY
Correspondent
THE ANSPACH EFFORT, INC.
4500 RIVERSIDE DR.
PALM BEACH GARDENS,  FL  33410
Correspondent Contact JEANNETTE G DAILEY
Regulation Number882.4360
Classification Product Code
HBC  
Subsequent Product Code
ERL  
Date Received11/25/2013
Decision Date 01/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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