The following data is part of a premarket notification filed by Rocket Of London, Ltd. with the FDA for Intrauterine Sound.
| Device ID | K935665 |
| 510k Number | K935665 |
| Device Name: | INTRAUTERINE SOUND |
| Classification | Sound, Uterine |
| Applicant | ROCKET OF LONDON, LTD. WEAR INDUSTRIAL ESTATE WASHINGTON Tyne & Wear, GB Ne37 1ne |
| Contact | L. Todd |
| Correspondent | L. Todd ROCKET OF LONDON, LTD. WEAR INDUSTRIAL ESTATE WASHINGTON Tyne & Wear, GB Ne37 1ne |
| Product Code | HHM |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-26 |
| Decision Date | 1994-02-24 |