The following data is part of a premarket notification filed by Allwin Medical Devices, Inc. with the FDA 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).
| Device ID | K190590 |
| 510k Number | K190590 |
| Device Name: | 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) |
| Classification | Needle, Assisted Reproduction |
| Applicant | Allwin Medical Devices, Inc. 3305 E. Miraloma Avenue, Suite 176 Anaheim, CA 92806 |
| Contact | Digish Mehta |
| Correspondent | Digish Mehta Allwin Medical Devices, Inc. 3305 E. Miraloma Avenue, Suite 176 Anaheim, CA 92806 |
| Product Code | MQE |
| CFR Regulation Number | 884.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-07 |
| Decision Date | 2019-11-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10812261016877 | K190590 | 000 |