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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 K954882
Device Name RIZA-RIBE NEEDLE (MODIFICATION)
Applicant
R-Med, Inc.
3465 Navarre Ave.
Box 167636
Oregon,  OH  43616
Applicant Contact E. D RIZA
Correspondent
R-Med, Inc.
3465 Navarre Ave.
Box 167636
Oregon,  OH  43616
Correspondent Contact E. D RIZA
Regulation Number888.1100
Classification Product Code
HRX  
Date Received08/10/1995
Decision Date 11/16/1995
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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