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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 K962880
Device Name SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM
Applicant
SHERWOOD MEDICAL CO.
1915 OLIVE ST.
ST. LOUIS,  MO  63103 -1642
Applicant Contact DENNIS POZZO
Correspondent
SHERWOOD MEDICAL CO.
1915 OLIVE ST.
ST. LOUIS,  MO  63103 -1642
Correspondent Contact DENNIS POZZO
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received07/24/1996
Decision Date 12/09/1996
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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