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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lavage, Jet
510(k) Number K854737
Device Name SURGICAL IRRIGATION DEVICE (SID)/ARTHROSCOPIC SURG
Applicant
Orthopaedic Devices , Ltd.
1889 S. 1800 W.
Woods Cross,  UT  84087
Applicant Contact RICHARD W BAGGETT
Correspondent
Orthopaedic Devices , Ltd.
1889 S. 1800 W.
Woods Cross,  UT  84087
Correspondent Contact RICHARD W BAGGETT
Regulation Number880.5475
Classification Product Code
FQH  
Date Received11/26/1985
Decision Date 05/19/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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