Allwin Intra Uterine Insemination Catheters (INSEMINA And INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED And CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE And TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLE

Catheter, Assisted Reproduction

Allwin Medical Devices, Inc.

The following data is part of a premarket notification filed by Allwin Medical Devices, Inc. with the FDA for Allwin Intra Uterine Insemination Catheters (insemina And Insemina Open Tip Intra Uterine Insemination Catheter, Curved And Curved Open Tip Intra Uterine Insemination Catheter, Trackable And Trackable Open Tip Intra Uterine Insemination Catheter, Fle.

Pre-market Notification Details

Device IDK190522
501k NumberK190522
Device Name:Allwin Intra Uterine Insemination Catheters (INSEMINA And INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED And CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE And TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLE
ClassificationCatheter, Assisted Reproduction
Applicant Allwin Medical Devices, Inc. 3305 E. Miraloma Avenue, Suite 176 Anaheim,  CA  92806
ContactDigish Mehta
CorrespondentDigish Mehta
Allwin Medical Devices, Inc. 3305 E. Miraloma Avenue, Suite 176 Anaheim,  CA  92806
Product CodeMQF  
CFR Regulation Number884.6110 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyObstetrics/Gynecology
501k Review PanelObstetrics/Gynecology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-04
Decision Date2019-11-14

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