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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 K163412
Device Name Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)
Girgis Scope LLC
2 Stonegate Drive
Monroe Township,  NJ  08831
Applicant Contact Madgy S. Girgis
Smith Associates
1468 Harwell Avenue
Crofton,  MD  21114
Correspondent Contact E. J. Smith
Regulation Number868.5540
Classification Product Code
Date Received12/05/2016
Decision Date 06/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No