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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 K981543
Device Name OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENT
Applicant
THE OLYMPUS OPTICAL CO.
ENDOSCOPE DIVISION
TWO CORPORATE CENTER DRIVE
MELVILLE,  NY  11747 -3157
Applicant Contact LAURA STORMS-TYLER
Correspondent
THE OLYMPUS OPTICAL CO.
ENDOSCOPE DIVISION
TWO CORPORATE CENTER DRIVE
MELVILLE,  NY  11747 -3157
Correspondent Contact LAURA STORMS-TYLER
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received04/30/1998
Decision Date 06/08/1998
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
Recalls CDRH Recalls
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