The following data is part of a premarket notification filed by Tactyl Technologies, Inc. with the FDA for Lubricated Condom.
| Device ID | K953583 |
| 510k Number | K953583 |
| Device Name: | LUBRICATED CONDOM |
| Classification | Condom |
| Applicant | TACTYL TECHNOLOGIES, INC. 2595 COMMERCE WAY Vista, CA 92083 |
| Contact | Jorge Haider |
| Correspondent | Jorge Haider TACTYL TECHNOLOGIES, INC. 2595 COMMERCE WAY Vista, CA 92083 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-01 |
| Decision Date | 1996-01-26 |