The following data is part of a premarket notification filed by Line One Laboratories with the FDA for Trustex Cola Flavord Condom.
Device ID | K964598 |
510k Number | K964598 |
Device Name: | TRUSTEX COLA FLAVORD CONDOM |
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 | 1996-11-18 |
Decision Date | 1997-02-14 |