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 |