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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 K951199
Device Name FB-18X, FIBER BRONCHOSCOPE
Applicant
PENTAX PRECISION INSTRUMENT CORP.
3117 COMMERCE PKWY.
MIRAMAR,  FL  33025
Applicant Contact PAUL SILVA
Correspondent
PENTAX PRECISION INSTRUMENT CORP.
3117 COMMERCE PKWY.
MIRAMAR,  FL  33025
Correspondent Contact PAUL SILVA
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received03/16/1995
Decision Date 04/10/1995
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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