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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K052572
Device Name ANSPACH KNOTLESS ANCHOR
Applicant
THE ANSPACH EFFORT, INC.
4500 RIVERSIDE DR.
PALM BEACH GARDENS,  FL  33410
Applicant Contact WILLIAM CONETY
Correspondent
THE ANSPACH EFFORT, INC.
4500 RIVERSIDE DR.
PALM BEACH GARDENS,  FL  33410
Correspondent Contact WILLIAM CONETY
Regulation Number888.3040
Classification Product Code
MBI  
Date Received09/19/2005
Decision Date 12/05/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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