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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
Applicant
The Anspach Effort, Inc.
4500 Riverside Dr.
Palm Beach Gardens,  FL  33410
Applicant Contact WILLIAM E ANSPACH III
Correspondent
The Anspach Effort, Inc.
4500 Riverside Dr.
Palm Beach Gardens,  FL  33410
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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