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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 K883830
Device Name FIBER OPTIC LARYNGOSCOPE
Applicant
Effner, Inc.
Post Office Box 191
Port Washington,  NY  11050
Applicant Contact INGE HAMER
Correspondent
Effner, Inc.
Post Office Box 191
Port Washington,  NY  11050
Correspondent Contact INGE HAMER
Regulation Number868.5540
Classification Product Code
CCW  
Date Received09/09/1988
Decision Date 10/25/1988
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
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