The following data is part of a premarket notification filed by Mayer Laboratories, Inc. with the FDA for Kimono Microthin With Aqua Lube, Reality Ultra Lubricated.
| Device ID | K113686 |
| 510k Number | K113686 |
| Device Name: | KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED |
| Classification | Condom |
| Applicant | MAYER LABORATORIES, INC. 1950 ADDISON STREET, SUITE 101 Berkely, CA 94704 -1182 |
| Contact | David P Mayer |
| Correspondent | David P Mayer MAYER LABORATORIES, INC. 1950 ADDISON STREET, SUITE 101 Berkely, CA 94704 -1182 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-15 |
| Decision Date | 2012-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850002174311 | K113686 | 000 |
| 00850002174304 | K113686 | 000 |