H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005

Cannula, Manipulator/injector, Uterine

ACKARD LABORATORIES

The following data is part of a premarket notification filed by Ackard Laboratories with the FDA for H/s Elliptosphere Catheter Set, Model 61-4005.

Pre-market Notification Details

Device IDK013972
510k NumberK013972
Device Name:H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005
ClassificationCannula, Manipulator/injector, Uterine
Applicant ACKARD LABORATORIES 70 JACKSON DR. P.O. BOX 1085 Cranford,  NJ  07016
ContactRichard Hettenbach
CorrespondentRichard Hettenbach
ACKARD LABORATORIES 70 JACKSON DR. P.O. BOX 1085 Cranford,  NJ  07016
Product CodeLKF  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-12-03
Decision Date2001-12-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20888937016455 K013972 000
20888937016448 K013972 000

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