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 IDK961752
510k NumberK961752
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
CorrespondentBernard Ackerman
ACKRAD LABORATORIES 70 JACKSON DR. Cranford,  NJ  07016
Product CodeLKF  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-05-06
Decision Date1996-08-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20888937016400 K961752 000
30888937016568 K961752 000
30888937016551 K961752 000
30612479162489 K961752 000
30612479162472 K961752 000

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