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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 K880181
Device Name REGANES DISPOSABLE EPIDURAL ANESTHESIA TRAY
Applicant
REGANES, INC.
P.O. BOX 13212
CLEARWATER,  FL  33519
Applicant Contact JOSEPH E HARMS
Correspondent
REGANES, INC.
P.O. BOX 13212
CLEARWATER,  FL  33519
Correspondent Contact JOSEPH E HARMS
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received01/15/1988
Decision Date 02/11/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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