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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Threaded
510(k) Number K982931
Device Name THREADED FIXATION PIN
Applicant
Sgarlato Laboratories, Inc.
250 Almendra Ave.
Los Gatos,  CA  95030
Applicant Contact THOMAS SGARLATO
Correspondent
Sgarlato Laboratories, Inc.
250 Almendra Ave.
Los Gatos,  CA  95030
Correspondent Contact THOMAS SGARLATO
Regulation Number888.3040
Classification Product Code
JDW  
Date Received08/20/1998
Decision Date 10/21/1998
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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