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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 K920800
Device Name INTEGRATED ENDOSCOPY SYSTEM 1000
Applicant
BIOMET, INC.
P.O. BOX 587
AIRPORT INDUSTRIAL PARK
WARSAW,  IN  46581 -0587
Applicant Contact PATRICIA S BERES
Correspondent
BIOMET, INC.
P.O. BOX 587
AIRPORT INDUSTRIAL PARK
WARSAW,  IN  46581 -0587
Correspondent Contact PATRICIA S BERES
Regulation Number888.1100
Classification Product Code
HRX  
Date Received02/21/1992
Decision Date 06/30/1992
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
Recalls CDRH Recalls
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