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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 K960619
Device Name MORE-L INJECTOR KIT PLUS
Applicant
Incutech, Inc.
307-A S. Westgate Dr.
Greensboro,  NC  27407
Applicant Contact ROGER MOLINA
Correspondent
Incutech, Inc.
307-A S. Westgate Dr.
Greensboro,  NC  27407
Correspondent Contact ROGER MOLINA
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received02/13/1996
Decision Date 06/20/1996
Decision Substantially Equivalent (SESE)
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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