The following data is part of a premarket notification filed by Mayer Laboratories with the FDA for Kimono (condoms).
| Device ID | K943064 |
| 510k Number | K943064 |
| Device Name: | KIMONO (CONDOMS) |
| Classification | Condom |
| Applicant | MAYER LABORATORIES 231 FALLON ST. Oakland, CA 94607 |
| Contact | David P Mayer |
| Correspondent | David P Mayer MAYER LABORATORIES 231 FALLON ST. Oakland, CA 94607 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-03 |
| Decision Date | 1995-09-22 |