The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Coopersurgical Oocyte Recovery Needles.
| Device ID | K023930 |
| 510k Number | K023930 |
| Device Name: | COOPERSURGICAL OOCYTE RECOVERY NEEDLES |
| Classification | Needle, Assisted Reproduction |
| Applicant | COOPERSURGICAL, INC. P.O. BOX 2156 Huntington, CT 06484 |
| Contact | Joseph M Azary |
| Correspondent | Joseph M Azary COOPERSURGICAL, INC. P.O. BOX 2156 Huntington, CT 06484 |
| Product Code | MQE |
| CFR Regulation Number | 884.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-25 |
| Decision Date | 2003-01-22 |
| Summary: | summary |