`THE INSEMINATOR' (PROPOSED)

Cannula, Intrauterine Insemination

WALLACH SURGICAL DEVICES, INC.

The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for `the Inseminator' (proposed).

Pre-market Notification Details

Device IDK984306
510k NumberK984306
Device Name:`THE INSEMINATOR' (PROPOSED)
ClassificationCannula, Intrauterine Insemination
Applicant WALLACH SURGICAL DEVICES, INC. 235 EDISON RD. Orange,  CT  06477
ContactMichael Malis
CorrespondentMichael Malis
WALLACH SURGICAL DEVICES, INC. 235 EDISON RD. Orange,  CT  06477
Product CodeMFD  
CFR Regulation Number884.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-12-02
Decision Date1999-03-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00888937011494 K984306 000
20888937011481 K984306 000
20888937011474 K984306 000

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