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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fixation Accessory
510(k) Number K912762
Device Name K-CAP-I, STERILE
Applicant
Westcon Orthopedics, Inc.
P.O. Box 337
Three Bridges,  NJ  08887
Applicant Contact DONN M GORDON
Correspondent
Westcon Orthopedics, Inc.
P.O. Box 337
Three Bridges,  NJ  08887
Correspondent Contact DONN M GORDON
Regulation Number888.3030
Classification Product Code
LYT  
Date Received06/24/1991
Decision Date 07/18/1991
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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