The following data is part of a premarket notification filed by Innolatex Sdn. Bhd with the FDA for Innolatex Male Latex Condoms Colored And Scented.
| Device ID | K041837 |
| 510k Number | K041837 |
| Device Name: | INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED |
| Classification | Condom |
| Applicant | INNOLATEX SDN. BHD 1219 LITTLE CREEK ROAD Durham, NC 27713 |
| Contact | Eli J Carter |
| Correspondent | Eli J Carter INNOLATEX SDN. BHD 1219 LITTLE CREEK ROAD Durham, NC 27713 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-07 |
| Decision Date | 2004-09-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812420030020 | K041837 | 000 |
| 00812420030181 | K041837 | 000 |
| 00812420030259 | K041837 | 000 |
| 10812420030188 | K041837 | 000 |
| 20812420030185 | K041837 | 000 |
| 10812420030010 | K041837 | 000 |
| 20812420030024 | K041837 | 000 |
| 20812420030000 | K041837 | 000 |
| 20812420030017 | K041837 | 000 |
| 00812420030006 | K041837 | 000 |
| 00812420030013 | K041837 | 000 |
| 00812420030242 | K041837 | 000 |