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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name screw, fixation, bone
510(k) Number K945525
Device Name ANSPACH SUTURE ANCHOR
Original Applicant
THE ANSPACH EFFORT, INC.
4500 riverside dr.
palm beach gardens,  FL  33410
Original Contact william e anspach iii
Regulation Number888.3040
Classification Product Code
HWC  
Date Received11/10/1994
Decision Date 07/11/1995
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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