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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Otoscope
510(k) Number K924025
Device Name OTO-BRITE HANDLE
Applicant
Jedmed Instrument Co.
6096 Lemay Ferry Rd.
St.Louis,  MO  63129
Applicant Contact CRAIG RAPP
Correspondent
Jedmed Instrument Co.
6096 Lemay Ferry Rd.
St.Louis,  MO  63129
Correspondent Contact CRAIG RAPP
Regulation Number874.4770
Classification Product Code
ERA  
Date Received08/11/1992
Decision Date 11/06/1992
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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