H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)

Cannula, Manipulator/injector, Uterine

ACKRAD LABORATORIES

The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for H/s Catheter Set(61-3005, 61-3007, 61-3605, 61-3607).

Pre-market Notification Details

Device IDK953034
510k NumberK953034
Device Name:H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
ClassificationCannula, Manipulator/injector, Uterine
Applicant ACKRAD LABORATORIES 70 JACKSON DR. Cranford,  NJ  07016
ContactBernard Ackerman, Ph.d.
CorrespondentBernard Ackerman, Ph.d.
ACKRAD LABORATORIES 70 JACKSON DR. Cranford,  NJ  07016
Product CodeLKF  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-19
Decision Date1995-08-29

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