The following data is part of a premarket notification filed by Line One Laboratories with the FDA for Trustex Mint Flavored Condom In Green Color, Impulse Mint Flavored Condom In Green Color.
Device ID | K991892 |
510k Number | K991892 |
Device Name: | TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN 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 | 1999-06-03 |
Decision Date | 1999-08-19 |