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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, Hemi-, Femoral, Metal Ball
510(k) Number K915548
Device Name IONGUARD TITANIUM MODULAR HEADS
Applicant
Biomet, Inc.
P.O. Box 587
Airport Industrial Park
Warsaw,  IN  46581
Applicant Contact PATRICIA S BERES
Correspondent
Biomet, Inc.
P.O. Box 587
Airport Industrial Park
Warsaw,  IN  46581
Correspondent Contact PATRICIA S BERES
Regulation Number888.3360
Classification Product Code
LZY  
Date Received12/11/1991
Decision Date 03/10/1992
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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