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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 K022853
Device Name ENDOTACK
Applicant
KARL STORZ Endoscopy-America, Inc.
600 Corporate Pointe
Culver City,  CA  90230 -7600
Applicant Contact JAMES A LEE
Correspondent
KARL STORZ Endoscopy-America, Inc.
600 Corporate Pointe
Culver City,  CA  90230 -7600
Correspondent Contact JAMES A LEE
Regulation Number888.3040
Classification Product Code
MBI  
Date Received08/27/2002
Decision Date 11/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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