The following data is part of a premarket notification filed by Ansell, Inc. with the FDA for Ansell Condoms.
| Device ID | K984392 |
| 510k Number | K984392 |
| Device Name: | ANSELL CONDOMS |
| Classification | Condom |
| Applicant | ANSELL, INC. 1500 INDUSTRIAL RD. Dothan, AL 36303 |
| Contact | Lon Mcllvain |
| Correspondent | Lon Mcllvain ANSELL, INC. 1500 INDUSTRIAL RD. Dothan, AL 36303 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-08 |
| Decision Date | 1999-07-21 |
| Summary: | summary |