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FDA 510(k) Application Details - K163412
Device Classification Name
Laryngoscope, Rigid
More FDA Info for this Device
510(K) Number
K163412
Device Name
Laryngoscope, Rigid
Applicant
Girgis Scope LLC
2 Stonegate Drive
Monroe Township, NJ 08831 US
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Contact
Madgy S. Girgis
Other 510(k) Applications for this Contact
Regulation Number
868.5540
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Classification Product Code
CCW
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More FDA Info for this Product Code
Date Received
12/05/2016
Decision Date
06/22/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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