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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 K902567
Device Name STAPLE, SERRATED, FIXATION W/SPIKES, VARIOUS SIZES
Applicant
A. Henniss
18321 Ventura Blvd.,
Suite 1010
Tarzana,  CA  91356
Applicant Contact GEORGE O SHECTER
Correspondent
A. Henniss
18321 Ventura Blvd.,
Suite 1010
Tarzana,  CA  91356
Correspondent Contact GEORGE O SHECTER
Regulation Number888.3030
Classification Product Code
JDR  
Date Received06/11/1990
Decision Date 07/10/1990
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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