The following data is part of a premarket notification filed by Mayer Laboratories with the FDA for Kimono Plus.
Device ID | K904375 |
510k Number | K904375 |
Device Name: | KIMONO PLUS |
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 | 1990-09-25 |
Decision Date | 1990-11-26 |