The following data is part of a premarket notification filed by Line One Laboratories with the FDA for Tustex Flavored Condoms.
| Device ID | K970633 |
| 510k Number | K970633 |
| Device Name: | TUSTEX FLAVORED CONDOMS |
| Classification | Condom |
| Applicant | LINE ONE LABORATORIES 121 WEST ELMYRA ST. Los Angeles, CA 90012 |
| Contact | Robert Gruber |
| Correspondent | Robert Gruber LINE ONE LABORATORIES 121 WEST ELMYRA ST. Los Angeles, CA 90012 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-20 |
| Decision Date | 1997-03-21 |