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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 K945484
Device Name PIDURAL STEROID SYSTEM
Applicant
Professional Medical Device Consultants
561 E. Fairoaks Way
Sandy,  UT  84070
Applicant Contact JOHN B ROWE
Correspondent
Professional Medical Device Consultants
561 E. Fairoaks Way
Sandy,  UT  84070
Correspondent Contact JOHN B ROWE
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received11/08/1994
Decision Date 06/02/1995
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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