Last synced on 20 January 2023 at 11:05 pm

Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190590
510(k) Type
Traditional
Applicant
Allwin Medical Devices, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/25/2019
Days to Decision
263 days
Submission Type
Statement

Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190590
510(k) Type
Traditional
Applicant
Allwin Medical Devices, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/25/2019
Days to Decision
263 days
Submission Type
Statement