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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 K941718
Device Name 3M FLUID CONTROL SYSTEM 8300 CASSETTE LOAD
Applicant
3M Medical Products Group
3m Center, Bldg. 275-3e-08
P.O. Box 33275
St. Paul,  MN  55144
Applicant Contact WILLARD LARSON
Correspondent
3M Medical Products Group
3m Center, Bldg. 275-3e-08
P.O. Box 33275
St. Paul,  MN  55144
Correspondent Contact WILLARD LARSON
Regulation Number888.1100
Classification Product Code
HRX  
Date Received04/07/1994
Decision Date 10/07/1994
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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