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FDA 510(k) Application Details - K203626
Device Classification Name
Labware, Assisted Reproduction
More FDA Info for this Device
510(K) Number
K203626
Device Name
Labware, Assisted Reproduction
Applicant
Allwin Medical Devices, Inc
3305 E. Miraloma Avenue, Suite 176
Anaheim, CA 92806 US
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Contact
Digish Mehta
Other 510(k) Applications for this Contact
Regulation Number
884.6160
More FDA Info for this Regulation Number
Classification Product Code
MQK
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More FDA Info for this Product Code
Date Received
12/11/2020
Decision Date
06/04/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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