The following data is part of a premarket notification filed by Ansell, Inc. with the FDA for Extra Strong Condom.
| Device ID | K864400 |
| 510k Number | K864400 |
| Device Name: | EXTRA STRONG CONDOM |
| Classification | Condom |
| Applicant | ANSELL, INC. INDUSTRIAL RD. POST OFFICE BOX 1252 Dothan, AL 36302 |
| Contact | Bradley Pugh |
| Correspondent | Bradley Pugh 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 | 1986-11-06 |
| Decision Date | 1987-02-02 |