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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 K883414
FOIA Releasable 510(k) K883414
Device Name LARYNGOSCOPE BLADES
Applicant
TRUPHATEK, LTD.
P.O. BOX 8051
NETANYA,  IL 42106
Applicant Contact DAVID GREY
Correspondent
TRUPHATEK, LTD.
P.O. BOX 8051
NETANYA,  IL 42106
Correspondent Contact DAVID GREY
Regulation Number868.5540
Classification Product Code
CCW  
Date Received08/15/1988
Decision Date 08/19/1988
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
Recalls CDRH Recalls
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