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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K020761
Device Name POWER TEK II
Applicant
Biomet, Inc.
56 E Bell Dr.
Warsaw,  IN  46581
Applicant Contact PATRICIA S BERES
Correspondent
Biomet, Inc.
56 E Bell Dr.
Warsaw,  IN  46581
Correspondent Contact PATRICIA S BERES
Regulation Number888.1100
Classification Product Code
HRX  
Date Received03/07/2002
Decision Date 04/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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