The following data is part of a premarket notification filed by Hardcover Products, Inc. with the FDA for Hardcover Condoms Male Latex Condoms, (with Spermicide).
| Device ID | K991047 |
| 510k Number | K991047 |
| Device Name: | HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE) |
| Classification | Condom With Nonoxynol-9 |
| Applicant | HARDCOVER PRODUCTS, INC. 55 ADMINISTRATION RD., UNIT 12 Concord, Ontario, CA L4k 4g9 |
| Contact | Gerry Person |
| Correspondent | Gerry Person HARDCOVER PRODUCTS, INC. 55 ADMINISTRATION RD., UNIT 12 Concord, Ontario, CA L4k 4g9 |
| Product Code | LTZ |
| CFR Regulation Number | 884.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-30 |
| Decision Date | 1999-06-18 |