The following data is part of a premarket notification filed by Ansell, Inc. with the FDA for Nuda-plus Condom W/spermicidal Lubricant.
| Device ID | K822792 |
| 510k Number | K822792 |
| Device Name: | NUDA-PLUS CONDOM W/SPERMICIDAL LUBRICANT |
| Classification | Condom |
| Applicant | ANSELL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-15 |
| Decision Date | 1982-09-30 |