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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anesthesia Conduction Kit
510(k) Number K885278
Device Name EPIDURAL ANESTHESIA TRAY
Applicant
Preferred Medical Products
100 W. Beaver Creek Rd.Unit
21,Ont.
Richmond Hill L4b1h4,  CA
Applicant Contact JOHN ROSCHUK
Correspondent
Preferred Medical Products
100 W. Beaver Creek Rd.Unit
21,Ont.
Richmond Hill L4b1h4,  CA
Correspondent Contact JOHN ROSCHUK
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received12/23/1988
Decision Date 03/16/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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