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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 K844776
Device Name EFFNER-SALING LARYNGOSCOPE FOR NEW-BORN
Applicant
MEDICAL INSTRUMENTS AND LAMPS
P.O. BOX 1139
PORT WASHINGTON,  NY  11050
Applicant Contact EMMANUEL ANAPLIOTIS
Correspondent
MEDICAL INSTRUMENTS AND LAMPS
P.O. BOX 1139
PORT WASHINGTON,  NY  11050
Correspondent Contact EMMANUEL ANAPLIOTIS
Regulation Number868.5540
Classification Product Code
CCW  
Date Received12/10/1984
Decision Date 10/01/1985
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
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