The following data is part of a premarket notification filed by Laboratoire Ccd C/o Washington Regulatory Services with the FDA for Endocyte, Disposable Endometrial Sampler.
| Device ID | K881220 |
| 510k Number | K881220 |
| Device Name: | ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER |
| Classification | Brush, Endometrial |
| 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 | HFE |
| CFR Regulation Number | 884.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-22 |
| Decision Date | 1988-06-14 |