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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K831240
Device Name LASER BRONCHOSCOPE
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 Number874.4680
Classification Product Code
EOQ  
Date Received04/15/1983
Decision Date 07/26/1983
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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