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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laryngoscope, Rigid
510(k) Number K984101
Device Name FLEXIBLADE
Applicant
Arco Medic , Ltd.
117 Ahuzah St.
Ra'Ananna 43373,  IL 43373
Applicant Contact SHOSHANA FRIEDMAN
Correspondent
Arco Medic , Ltd.
117 Ahuzah St.
Ra'Ananna 43373,  IL 43373
Correspondent Contact SHOSHANA FRIEDMAN
Regulation Number868.5540
Classification Product Code
CCW  
Date Received11/17/1998
Decision Date 09/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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