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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
510(k) Number K010827
Device Name COPELAND MB/HA RESURFACING HUMERAL HEADS
Applicant
Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact SARA A BAILEY
Correspondent
Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact SARA A BAILEY
Regulation Number888.3690
Classification Product Code
HSD  
Date Received03/20/2001
Decision Date 09/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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