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FDA 510(k) Application Details - K190590
Device Classification Name
Needle, Assisted Reproduction
More FDA Info for this Device
510(K) Number
K190590
Device Name
Needle, 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
884.6100
More FDA Info for this Regulation Number
Classification Product Code
MQE
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More FDA Info for this Product Code
Date Received
03/07/2019
Decision Date
11/25/2019
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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