The following data is part of a premarket notification filed by Mayer Laboratories, Inc. with the FDA for Aqua Lube Natural Lubricant - Regular, Warming.
| Device ID | K130345 |
| 510k Number | K130345 |
| Device Name: | AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING |
| Classification | Lubricant, Personal |
| 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 | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-11 |
| Decision Date | 2013-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20016169530047 | K130345 | 000 |
| 20016169530023 | K130345 | 000 |
| 10016169515047 | K130345 | 000 |
| 20016169515020 | K130345 | 000 |