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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 K811059
Device Name PENTAX BRONCHOFIBERSCOPE #FB-15A
Applicant
PENTAX PRECISION INSTRUMENT CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PENTAX PRECISION INSTRUMENT CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received04/17/1981
Decision Date 05/27/1981
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
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