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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 K113028
Device Name MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS
Applicant
MEDISISS
2747 SW 6TH STREET
REDMOND,  OR  97756
Applicant Contact JOYCE ELKINS
Correspondent
MEDISISS
2747 SW 6TH STREET
REDMOND,  OR  97756
Correspondent Contact JOYCE ELKINS
Regulation Number888.1100
Classification Product Code
HRX  
Date Received10/11/2011
Decision Date 12/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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