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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 K914181
Device Name WANG/MILL-ROSE TRANSBRONCHIAL ASPIRATION NEEDLE
Applicant
MILL-ROSE LABORATORY
7310 CORPORATE BLVD.
MENTOR,  OH  44060 -4885
Applicant Contact ALAN C POJE
Correspondent
MILL-ROSE LABORATORY
7310 CORPORATE BLVD.
MENTOR,  OH  44060 -4885
Correspondent Contact ALAN C POJE
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received09/18/1991
Decision Date 12/10/1991
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
Recalls CDRH Recalls
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