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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K914803
Device Name SCHWABE RADIUS PLATES
Applicant
Link America, Inc.
C/O Surgical Implants, Inc.
10 Great Meadow Ln.
East Hanavor,  NJ  07936
Applicant Contact MR E SCHUSSLER
Correspondent
Link America, Inc.
C/O Surgical Implants, Inc.
10 Great Meadow Ln.
East Hanavor,  NJ  07936
Correspondent Contact MR E SCHUSSLER
Regulation Number888.3030
Classification Product Code
HRS  
Date Received10/24/1991
Decision Date 04/28/1992
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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