The following data is part of a premarket notification filed by Laboratoire Ccd C/o Washington Regulatory Services with the FDA for Resubmitted Artificial Insemination Instrument Set.
| Device ID | K884696 |
| 510k Number | K884696 |
| Device Name: | RESUBMITTED ARTIFICIAL INSEMINATION INSTRUMENT SET |
| Classification | Cap, Cervical |
| Applicant | LABORATOIRE CCD C/O WASHINGTON REGULATORY SERVICES 23 WELISEWITZ RD. Ringoes, NJ 08551 |
| Contact | Randolph L Cooke |
| Correspondent | Randolph L Cooke LABORATOIRE CCD C/O WASHINGTON REGULATORY SERVICES 23 WELISEWITZ RD. Ringoes, NJ 08551 |
| Product Code | HDR |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-09 |
| Decision Date | 1989-01-27 |