The following data is part of a premarket notification filed by Mayer Laboratories with the FDA for Kimono Microthin.
| Device ID | K946374 |
| 510k Number | K946374 |
| Device Name: | KIMONO MICROTHIN |
| Classification | Condom |
| Applicant | MAYER LABORATORIES 231 FALLON ST. Oakland, CA 94607 |
| Contact | David Mayer |
| Correspondent | David 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 | 1994-12-14 |
| Decision Date | 1995-11-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850002174182 | K946374 | 000 |
| 00850002174175 | K946374 | 000 |