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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Airway, Oropharyngeal, Anesthesiology
510(k) Number K861482
Device Name RESUSIKIT
Applicant
Begley Enterprises, Inc.
200 Walker Dr.
Suite #6
Pendleton,  IN  46064
Applicant Contact DIANA DICKERSON
Correspondent
Begley Enterprises, Inc.
200 Walker Dr.
Suite #6
Pendleton,  IN  46064
Correspondent Contact DIANA DICKERSON
Regulation Number868.5110
Classification Product Code
CAE  
Date Received04/22/1986
Decision Date 06/17/1986
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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