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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)
- 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