The following data is part of a premarket notification filed by Line One Laboratories with the FDA for Trustex Grape Flavored Condom In Purple Color.
| Device ID | K964591 |
| 510k Number | K964591 |
| Device Name: | TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR |
| Classification | Condom |
| Applicant | LINE ONE LABORATORIES 1481 EAST 4TH ST. Los Angeles, CA 90033 |
| Contact | Robert Gruber |
| Correspondent | Robert Gruber LINE ONE LABORATORIES 1481 EAST 4TH ST. Los Angeles, CA 90033 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-15 |
| Decision Date | 1997-02-13 |