The following data is part of a premarket notification filed by Mayer Laboratories with the FDA for Ez-on Condom.
| Device ID | K001974 |
| 510k Number | K001974 |
| Device Name: | EZ-ON CONDOM |
| Classification | Condom, Synthetic |
| Applicant | MAYER LABORATORIES 646 KENNEDY ST., BLDG. C Oakland, CA 94606 |
| Contact | David P Mayer |
| Correspondent | David P Mayer MAYER LABORATORIES 646 KENNEDY ST., BLDG. C Oakland, CA 94606 |
| Product Code | MOL |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-29 |
| Decision Date | 2001-10-24 |