ELECTRIC VACUM PUMP

Pump, Portable, Aspiration (manual Or Powered)

IMPACT INSTRUMENTATION, INC.

The following data is part of a premarket notification filed by Impact Instrumentation, Inc. with the FDA for Electric Vacum Pump.

Pre-market Notification Details

Device IDK941096
510k NumberK941096
Device Name:ELECTRIC VACUM PUMP
ClassificationPump, Portable, Aspiration (manual Or Powered)
Applicant IMPACT INSTRUMENTATION, INC. 27 FAIRFIELD PL. P.O. BOX 508 West Caldwell,  NJ  07006 -0508
ContactLeslie H Sherman
CorrespondentLeslie H Sherman
IMPACT INSTRUMENTATION, INC. 27 FAIRFIELD PL. P.O. BOX 508 West Caldwell,  NJ  07006 -0508
Product CodeBTA  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-03-07
Decision Date1995-01-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.