The following data is part of a premarket notification filed by Ansell, Inc. with the FDA for Non-lubricated Condom.
| Device ID | K940046 |
| 510k Number | K940046 |
| Device Name: | NON-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 | 1995-01-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 80070907101601 | K940046 | 000 |
| 18859798100534 | K940046 | 000 |
| 18859798104976 | K940046 | 000 |
| 18859798104952 | K940046 | 000 |