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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K920756
Device Name FELDMUHLE CERAMIC HEAD
Applicant
Link America, Inc.
321 Palmer Rd.
Denville,  NJ  07834
Applicant Contact EDWARD B SCHUSSLER
Correspondent
Link America, Inc.
321 Palmer Rd.
Denville,  NJ  07834
Correspondent Contact EDWARD B SCHUSSLER
Regulation Number888.3353
Classification Product Code
LZO  
Date Received02/19/1992
Decision Date 05/18/1992
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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