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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 K190522
Device Name Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter)
Applicant
Allwin Medical Devices, Inc.
3305 E. Miraloma Avenue, Suite 176
Anaheim,  CA  92806
Applicant Contact Digish Mehta
Correspondent
Allwin Medical Devices, Inc.
3305 E. Miraloma Avenue, Suite 176
Anaheim,  CA  92806
Correspondent Contact Digish Mehta
Regulation Number884.6110
Classification Product Code
MQF  
Subsequent Product Code
MFD  
Date Received03/04/2019
Decision Date 11/14/2019
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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