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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 K950054
Device Name ENDO-BEND(TM) SHAVER
Applicant
Paladin Medical, Inc.
P.O. Box 560
Stillwater,  MN  55082
Applicant Contact ELAINE DUNCAN
Correspondent
Paladin Medical, Inc.
P.O. Box 560
Stillwater,  MN  55082
Correspondent Contact ELAINE DUNCAN
Regulation Number888.1100
Classification Product Code
HRX  
Date Received01/06/1995
Decision Date 06/29/1995
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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