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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Labware, Assisted Reproduction
510(k) Number K203626
Device Name SureStrip Vitrification Straw, SureLock Vitrification Straw
Applicant
Allwin Medical Devices, Inc.
3305 E. Mira Loma Ave., Suite 176
Anaheim,  CA  92806
Applicant Contact Digish Mehta
Correspondent
Allwin Medical Devices, Inc.
3305 E. Mira Loma Ave., Suite 176
Anaheim,  CA  92806
Correspondent Contact Digish Mehta
Regulation Number884.6160
Classification Product Code
MQK  
Date Received12/11/2020
Decision Date 06/04/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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