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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps
510(k) Number K871535
Device Name SMILJANIC BONE REPOSITIONING FORCEPS
Applicant
Link America, Inc.
C/O Surgical Implants, Inc.
10 Great Meadow Ln.
East Hanavor,  NJ  07936
Applicant Contact EDWARD B SCHUSSLER
Correspondent
Link America, Inc.
C/O Surgical Implants, Inc.
10 Great Meadow Ln.
East Hanavor,  NJ  07936
Correspondent Contact EDWARD B SCHUSSLER
Regulation Number878.4800
Classification Product Code
HTD  
Date Received04/20/1987
Decision Date 05/14/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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