The following data is part of a premarket notification filed by Sensicon Corp. with the FDA for Tactylon Condom.
| Device ID | K971590 |
| 510k Number | K971590 |
| Device Name: | TACTYLON CONDOM |
| Classification | Condom, Synthetic |
| Applicant | SENSICON CORP. 2595 COMMERCE WAY Vista, CA 92083 |
| Contact | Jorge Haider |
| Correspondent | Jorge Haider 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 | 1997-05-01 |
| Decision Date | 1997-10-07 |
| Summary: | summary |