The following data is part of a premarket notification filed by Sensicon Corp. with the FDA for Lubricated Baggy Tactylon Condom.
| Device ID | K974121 |
| 510k Number | K974121 |
| Device Name: | LUBRICATED BAGGY TACTYLON CONDOM |
| Classification | Condom, Synthetic |
| Applicant | SENSICON CORP. 2595 COMMERCE WAY Vista, CA 92083 |
| Contact | Jeff D Grant |
| Correspondent | Jeff D Grant SENSICON CORP. 2595 COMMERCE WAY Vista, CA 92083 |
| Product Code | MOL |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-31 |
| Decision Date | 1998-01-29 |
| Summary: | summary |