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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 K911922
Device Name BRONCHOSCOPE ACCESSORY, NSN 6515-00-315-2200
Applicant
Delta Industries, Inc.
P.O. Box 50128
Idaho Falls,  ID  83405 -0128
Applicant Contact GEORGE S PRICE
Correspondent
Delta Industries, Inc.
P.O. Box 50128
Idaho Falls,  ID  83405 -0128
Correspondent Contact GEORGE S PRICE
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received04/30/1991
Decision Date 07/29/1991
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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