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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 K950929
Device Name SENSI-TOUCH EPIDURAL ANESTHESIA TRAY
Applicant
Sherwood Medical Co.
1915 Olive St.
St. Louis,  MO  63103
Applicant Contact FRANK FUCILE
Correspondent
Sherwood Medical Co.
1915 Olive St.
St. Louis,  MO  63103
Correspondent Contact FRANK FUCILE
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received03/01/1995
Decision Date 05/30/1995
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
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