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510(k) K203626

SureStrip Vitrification Straw, SureLock Vitrification Straw by Allwin Medical Devices, Inc. — Product Code MQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2021
Date Received
December 11, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Labware, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6160
Review Panel
OB
Submission Type

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  • K190590 — Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double (November 25, 2019)
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