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)— 510(k) K190590
Substantially EquivalentAllwin Medical Devices, Inc.
FDA 510(k) clearance K190590 for 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), Substantially Equivalent on 2019-11-25. Applicant: Allwin Medical Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- Allwin Medical Devices, Inc.
- Product code
- Code MQE
- Device class
- Class 2
- Regulation
- 21 CFR 884.6100
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Anaheim, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.