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 |