The following data is part of a premarket notification filed by Schmid Laboratories, Inc. with the FDA for Mint Scented Condoms.
Device ID | K900679 |
510k Number | K900679 |
Device Name: | MINT SCENTED CONDOMS |
Classification | Condom |
Applicant | SCHMID LABORATORIES, INC. ROUTE 46 WEST Little Falls, NJ 07424 |
Contact | Phyliss M Barber |
Correspondent | Phyliss M Barber SCHMID LABORATORIES, INC. ROUTE 46 WEST Little Falls, NJ 07424 |
Product Code | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-12 |
Decision Date | 1990-06-07 |