The following data is part of a premarket notification filed by Line One Laboratories & Trading Co. with the FDA for Trustex Flavor Condon In Colors.
| Device ID | K946103 |
| 510k Number | K946103 |
| Device Name: | TRUSTEX FLAVOR CONDON IN COLORS |
| Classification | Condom |
| Applicant | LINE ONE LABORATORIES & TRADING CO. P.O. BOX 861941 Los Angeles, CA 90086 |
| Contact | Budiman Lee |
| Correspondent | Budiman Lee LINE ONE LABORATORIES & TRADING CO. P.O. BOX 861941 Los Angeles, CA 90086 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-14 |
| Decision Date | 1996-07-15 |