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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
510(k) Number K941650
Device Name TOTAL TOE SYSTEM II
Applicant
Biomet, Inc.
Airport Industrial Park
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact PATRICIA SANDBORN BERES
Correspondent
Biomet, Inc.
Airport Industrial Park
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact PATRICIA SANDBORN BERES
Classification Product Code
LZJ  
Date Received04/05/1994
Decision Date 12/19/1994
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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