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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 K904465
Device Name FLEXIBLE ARTHROSCOPE
Applicant
INTRAMED LABORATORIES, INC.
11100 ROSELLE ST.
SAN DIEGO,  CA  92121
Applicant Contact ALDEN KAY
Correspondent
INTRAMED LABORATORIES, INC.
11100 ROSELLE ST.
SAN DIEGO,  CA  92121
Correspondent Contact ALDEN KAY
Regulation Number888.1100
Classification Product Code
HRX  
Date Received10/01/1990
Decision Date 12/20/1990
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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