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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K904340
Device Name FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM
Applicant
Neoligaments, Ltd.
99 Walnut St.
Suite B
Saugus,  MA  01906
Applicant Contact KENNETH E CARRIER
Correspondent
Neoligaments, Ltd.
99 Walnut St.
Suite B
Saugus,  MA  01906
Correspondent Contact KENNETH E CARRIER
Regulation Number888.3030
Classification Product Code
JDR  
Date Received09/20/1990
Decision Date 10/19/1990
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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