PENTAX BRONCHOFIBERSCOPE #FB-15A

Bronchoscope (flexible Or Rigid)

PENTAX PRECISION INSTRUMENT CORP.

The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Pentax Bronchofiberscope #fb-15a.

Pre-market Notification Details

Device IDK811059
510k NumberK811059
Device Name:PENTAX BRONCHOFIBERSCOPE #FB-15A
ClassificationBronchoscope (flexible Or Rigid)
Applicant PENTAX PRECISION INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-04-17
Decision Date1981-05-27

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