The following data is part of a premarket notification filed by Hardcover Products, Inc. with the FDA for Male Natural Rubber Latex Condom (with Lubrication).
| Device ID | K990925 |
| 510k Number | K990925 |
| Device Name: | MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION) |
| Classification | Condom |
| Applicant | HARDCOVER PRODUCTS, INC. 55 ADMINISTRATION RD., UNIT 12 Concord, Ontario, CA L4k 4g9 |
| Contact | Gerry Glazer |
| Correspondent | Gerry Glazer HARDCOVER PRODUCTS, INC. 55 ADMINISTRATION RD., UNIT 12 Concord, Ontario, CA L4k 4g9 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-19 |
| Decision Date | 1999-06-17 |