SureStrip Vitrification Straw, SureLock Vitrification Straw

Labware, 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 Surestrip Vitrification Straw, Surelock Vitrification Straw.

Pre-market Notification Details

Device IDK203626
510k NumberK203626
Device Name:SureStrip Vitrification Straw, SureLock Vitrification Straw
ClassificationLabware, 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 CodeMQK  
CFR Regulation Number884.6160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-11
Decision Date2021-06-04

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