WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM

Cannula, Intrauterine Insemination

MARLOW SURGICAL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Marlow Surgical Technologies, Inc. with the FDA for Wallace Artificial Insemination Catheter - 8cm/18cm.

Pre-market Notification Details

Device IDK964848
510k NumberK964848
Device Name:WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM
ClassificationCannula, Intrauterine Insemination
Applicant MARLOW SURGICAL TECHNOLOGIES, INC. 1810 JOSEPH LLOYD PKWY. Willoughby,  OH  44094
ContactArthur S Goddard
CorrespondentArthur S Goddard
MARLOW SURGICAL TECHNOLOGIES, INC. 1810 JOSEPH LLOYD PKWY. Willoughby,  OH  44094
Product CodeMFD  
CFR Regulation Number884.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-12-03
Decision Date1997-01-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30888937021333 K964848 000

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