Last synced on 30 September 2022 at 11:05 pm

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190522
510(k) Type
Traditional
Applicant
Allwin Medical Devices, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/14/2019
Days to Decision
255 days
Submission Type
Statement

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190522
510(k) Type
Traditional
Applicant
Allwin Medical Devices, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/14/2019
Days to Decision
255 days
Submission Type
Statement