The following data is part of a premarket notification filed by Mayer Laboratories with the FDA for Orion Plus W/nonoxynol-9 Others (multiple) Condoms.
| Device ID | K884469 |
| 510k Number | K884469 |
| Device Name: | ORION PLUS W/NONOXYNOL-9 OTHERS (MULTIPLE) CONDOMS |
| Classification | Condom |
| Applicant | MAYER LABORATORIES 1611 TELEGRAPH AVENUE, SUITE 830 Oakland, CA 94612 |
| Contact | David P Mayer |
| Correspondent | David P Mayer MAYER LABORATORIES 1611 TELEGRAPH AVENUE, SUITE 830 Oakland, CA 94612 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-25 |
| Decision Date | 1989-03-31 |