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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
510(k) Number K012694
Device Name REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS
Applicant
Adven Medical
1001 Slaton Hwy
Lubbock,  TX  79404
Applicant Contact MARK W ALDANA
Correspondent
Adven Medical
1001 Slaton Hwy
Lubbock,  TX  79404
Correspondent Contact MARK W ALDANA
Regulation Number878.4820
Classification Product Code
HWE  
Date Received08/14/2001
Decision Date 02/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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