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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 K945590
Device Name SCOPETEX(TM)
Applicant
SMITH HELMS MULLISS & MOORE, L.L.P.
POST OFFICE BOX 21927
GREENSBORO,  NC  27420
Applicant Contact CHRISTINE T NERO
Correspondent
SMITH HELMS MULLISS & MOORE, L.L.P.
POST OFFICE BOX 21927
GREENSBORO,  NC  27420
Correspondent Contact CHRISTINE T NERO
Regulation Number868.5540
Classification Product Code
CCW  
Date Received11/14/1994
Decision Date 05/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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