The following data is part of a premarket notification filed by Cupid Condom, Ltd. with the FDA for Green Love Male Contraceptive (condom).
Device ID | K051842 |
510k Number | K051842 |
Device Name: | GREEN LOVE MALE CONTRACEPTIVE (CONDOM) |
Classification | Condom |
Applicant | CUPID CONDOM, LTD. A-68, MIDC SINNAR, (MALEGAON) Nashik, Maharashtra, IN 422 113 |
Contact | K.k. Goyal |
Correspondent | K.k. Goyal CUPID CONDOM, LTD. A-68, MIDC SINNAR, (MALEGAON) Nashik, Maharashtra, IN 422 113 |
Product Code | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-07-07 |
Decision Date | 2006-04-14 |
Summary: | summary |