The following data is part of a premarket notification filed by Richard Van Haussen America, Inc. with the FDA for Caution Condoms.
| Device ID | K033163 |
| 510k Number | K033163 |
| Device Name: | CAUTION CONDOMS |
| Classification | Condom With Nonoxynol-9 |
| Applicant | RICHARD VAN HAUSSEN AMERICA, INC. 5777 W. CENTURY BLVD. #1648 Los Angeles, CA 90045 |
| Contact | Richard Quaison |
| Correspondent | Richard Quaison RICHARD VAN HAUSSEN AMERICA, INC. 5777 W. CENTURY BLVD. #1648 Los Angeles, CA 90045 |
| Product Code | LTZ |
| CFR Regulation Number | 884.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-11-07 |
| Decision Date | 2004-04-27 |