The following data is part of a premarket notification filed by Sxwell Usa Llc with the FDA for Synthetic Polyisoprene Lubricated Male Condom - 5 Senses.
| Device ID | K182438 |
| 510k Number | K182438 |
| Device Name: | Synthetic Polyisoprene Lubricated Male Condom - 5 Senses |
| Classification | Condom, Synthetic |
| Applicant | Sxwell Usa LLC 111 Wood Avenue South Iselin, NJ 08830 |
| Contact | Robert Mahler |
| Correspondent | Robert Mahler Sxwell Usa LLC 111 Wood Avenue South Iselin, NJ 08830 |
| Product Code | MOL |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-07 |
| Decision Date | 2018-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10070907231200 | K182438 | 000 |
| 10070907231026 | K182438 | 000 |
| 18859798100152 | K182438 | 000 |
| 18859798100688 | K182438 | 000 |
| 18859798100855 | K182438 | 000 |
| 18859798101500 | K182438 | 000 |