The following data is part of a premarket notification filed by Washington Regulatory Services with the FDA for Register, A Disposable Hysterography Cupula.
| Device ID | K894259 |
| 510k Number | K894259 |
| Device Name: | REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA |
| Classification | Insufflator, Hysteroscopic |
| Applicant | WASHINGTON REGULATORY SERVICES R.D. # 3 BOX 237 WELISEWITZ RD. Ringoes, NJ 08551 |
| Contact | Randolph Cooke |
| Correspondent | Randolph Cooke WASHINGTON REGULATORY SERVICES R.D. # 3 BOX 237 WELISEWITZ RD. Ringoes, NJ 08551 |
| Product Code | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-20 |
| Decision Date | 1990-03-05 |