T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES

Bottle, Collection, Vacuum

BOEHRINGER LABORATORIES

The following data is part of a premarket notification filed by Boehringer Laboratories with the FDA for T-vac Pleural Drainage Unit, 7800 Series.

Pre-market Notification Details

Device IDK861025
510k NumberK861025
Device Name:T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES
ClassificationBottle, Collection, Vacuum
Applicant BOEHRINGER LABORATORIES P.O. BOX 870 Norristown,  PA  19404
ContactJohn Boehringer
CorrespondentJohn Boehringer
BOEHRINGER LABORATORIES P.O. BOX 870 Norristown,  PA  19404
Product CodeKDQ  
CFR Regulation Number880.6740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-03-18
Decision Date1986-04-28

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