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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 K012073
Device Name OLYMPUS SPRAY CATHETER PW-6C-1
Applicant
THE OLYMPUS OPTICAL CO.
TWO CORPORATE DR.
MELVILLE,  NY  11747
Applicant Contact LAURA STORMS-TYLER
Correspondent
THE OLYMPUS OPTICAL CO.
TWO CORPORATE DR.
MELVILLE,  NY  11747
Correspondent Contact LAURA STORMS-TYLER
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received07/02/2001
Decision Date 08/10/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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