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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 K951870
Device Name MORELL INJECTOR
Applicant
INCUTECH, INC.
307-A SOUTH WESTGATE DR.
GREENSBORO,  NC  27407
Applicant Contact ROGER V MOLINA
Correspondent
INCUTECH, INC.
307-A SOUTH WESTGATE DR.
GREENSBORO,  NC  27407
Correspondent Contact ROGER V MOLINA
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received04/21/1995
Decision Date 01/22/1996
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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