IMPACT TURBO CATH

Catheter And Tip, Suction

IMPACT INSTRUMENTATION, INC.

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

Pre-market Notification Details

Device IDK851611
510k NumberK851611
Device Name:IMPACT TURBO CATH
ClassificationCatheter And Tip, Suction
Applicant IMPACT INSTRUMENTATION, INC. P.O. BOX 412 Bogota,  NJ  07603
ContactLeslie H Sherman
CorrespondentLeslie H Sherman
IMPACT INSTRUMENTATION, INC. P.O. BOX 412 Bogota,  NJ  07603
Product CodeJOL  
CFR Regulation Number880.6740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-04-09
Decision Date1985-06-05

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