The following data is part of a premarket notification filed by Ansell, Inc. with the FDA for Spermicidally Lubricated Condom.
| Device ID | K940047 |
| 510k Number | K940047 |
| Device Name: | SPERMICIDALLY LUBRICATED CONDOM |
| Classification | Condom |
| Applicant | ANSELL, INC. INDUSTRIAL RD. POST OFFICE BOX 1252 Dothan, AL 36302 |
| Contact | John Moushall |
| Correspondent | John Moushall ANSELL, INC. INDUSTRIAL RD. POST OFFICE BOX 1252 Dothan, AL 36302 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-05 |
| Decision Date | 1995-12-19 |