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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 K944031
Device Name VIDEO SCOPE SYSTEM (OTOSCOPE)
Applicant
Jedmed Instrument Co.
6096 Lemay Ferry Rd.
St.Louis,  MO  63129
Applicant Contact CRAIG R PARKS
Correspondent
Jedmed Instrument Co.
6096 Lemay Ferry Rd.
St.Louis,  MO  63129
Correspondent Contact CRAIG R PARKS
Regulation Number874.4770
Classification Product Code
ERA  
Date Received08/17/1994
Decision Date 09/23/1994
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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