The following data is part of a premarket notification filed by London International U.s. Holdings, Inc. with the FDA for Durex, Ramses, Sheik.
| Device ID | K952415 |
| 510k Number | K952415 |
| Device Name: | DUREX, RAMSES, SHEIK |
| Classification | Condom With Nonoxynol-9 |
| Applicant | LONDON INTERNATIONAL U.S. HOLDINGS, INC. 1819 MAIN ST., 8TH FLOOR P.O. BOX 4703 Sarasota, FL 34236 |
| Contact | Phyliss M Barber |
| Correspondent | Phyliss M Barber LONDON INTERNATIONAL U.S. HOLDINGS, INC. 1819 MAIN ST., 8TH FLOOR P.O. BOX 4703 Sarasota, FL 34236 |
| Product Code | LTZ |
| CFR Regulation Number | 884.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-23 |
| Decision Date | 1996-07-15 |