The following data is part of a premarket notification filed by Upsher-smith Laboratories, Inc. with the FDA for Condom-mate Vaginal Lubricant.
| Device ID | K881338 |
| 510k Number | K881338 |
| Device Name: | CONDOM-MATE VAGINAL LUBRICANT |
| Classification | Lubricant, Patient |
| Applicant | UPSHER-SMITH LABORATORIES, INC. 14905 23RD AVENUE NORTH Minneapolis, MN 55447 |
| Contact | Harvey M Arbit |
| Correspondent | Harvey M Arbit UPSHER-SMITH LABORATORIES, INC. 14905 23RD AVENUE NORTH Minneapolis, MN 55447 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-29 |
| Decision Date | 1988-05-16 |