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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laryngoscope, Nasopharyngoscope
510(k) Number K831255
Device Name LARYNGOSCOPE ATTACHMENT PH2000
Applicant
Eder Instrument Co, Inc.
735 N. Water St.
Suite 1102
Milwaukee, Wi 53202,  53202
Correspondent
Eder Instrument Co, Inc.
735 N. Water St.
Suite 1102
Milwaukee, Wi 53202,  53202
Regulation Number874.4760
Classification Product Code
EQN  
Date Received04/18/1983
Decision Date 09/12/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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