Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets And Soft Obturators

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 Embryo Transfer Catheters (etc), Allwin Etc Stylets And Soft Obturators.

Pre-market Notification Details

Device IDK200248
510k NumberK200248
Device Name:Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets And Soft Obturators
ClassificationCatheter, Assisted Reproduction
Applicant Allwin Medical Devices, Inc. 3305 East Mira Loma Avenue, STE 176 Anaheim,  CA  92806
ContactDigish Mehta
CorrespondentDigish Mehta
Allwin Medical Devices, Inc. 3305 East Mira Loma Avenue, STE 176 Anaheim,  CA  92806
Product CodeMQF  
CFR Regulation Number884.6110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-31
Decision Date2020-07-01

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