The following data is part of a premarket notification filed by Church & Dwight Co., Inc. with the FDA for Trojan-enz Brand.
| Device ID | K071313 |
| 510k Number | K071313 |
| Device Name: | TROJAN-ENZ BRAND |
| Classification | Condom |
| Applicant | CHURCH & DWIGHT CO., INC. 469 NORTH HARRISON STREET Princeton, NJ 08543 |
| Contact | Stephen C Kolakowsky |
| Correspondent | Stephen C Kolakowsky CHURCH & DWIGHT CO., INC. 469 NORTH HARRISON STREET Princeton, NJ 08543 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-10 |
| Decision Date | 2007-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00022600020165 | K071313 | 000 |
| 00022600019466 | K071313 | 000 |