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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Assisted Reproduction
510(k) Number K200248
Device Name Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators
Applicant
Allwin Medical Devices, Inc.
3305 East Mira Loma Avenue, STE 176
Anaheim,  CA  92806
Applicant Contact Digish Mehta
Correspondent
Allwin Medical Devices, Inc.
3305 East Mira Loma Avenue, STE 176
Anaheim,  CA  92806
Correspondent Contact Digish Mehta
Regulation Number884.6110
Classification Product Code
MQF  
Date Received01/31/2020
Decision Date 07/01/2020
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
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