The following data is part of a premarket notification filed by Cupid Limited with the FDA for Cupid Brand Male Natural Rubber Latex Condoms (plain (banana) , Plain (strawberry), Dotted , Multi-textured (dotted+contoured + Ribbed)).
| Device ID | K201067 |
| 510k Number | K201067 |
| Device Name: | CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed)) |
| Classification | Condom |
| Applicant | CUPID Limited A-68, M.I.D.C. (Malegaon), Sinnar Nashik, IN 422113 |
| Contact | Durgesh Garg |
| Correspondent | Manoj Zacharias Liberty Management Group Ltd. 75 Executive Drive, Suite 114 Aurora, IL 60504 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-22 |
| Decision Date | 2020-08-07 |