The following data is part of a premarket notification filed by Line One Laboratories & Trading Co. with the FDA for Ria Latex Condom & Ria Color Condoms (red, Green, Blue, Orange, Purple And Black).
| Device ID | K944786 |
| 510k Number | K944786 |
| Device Name: | RIA LATEX CONDOM & RIA COLOR CONDOMS (RED, GREEN, BLUE, ORANGE, PURPLE AND BLACK) |
| 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 | 1994-09-28 |
| Decision Date | 1995-12-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850002174885 | K944786 | 000 |
| 00850002174878 | K944786 | 000 |
| 00850002174854 | K944786 | 000 |
| 00850002174670 | K944786 | 000 |