The following data is part of a premarket notification filed by Line One Laboratories & Trading Co. with the FDA for Ria Latex Condom With Spermicide, Ria Color Condom With Spermicide.
Device ID | K945930 |
510k Number | K945930 |
Device Name: | RIA LATEX CONDOM WITH SPERMICIDE, RIA COLOR CONDOM WITH SPERMICIDE |
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 | 1994-12-05 |
Decision Date | 1995-12-19 |