The following data is part of a premarket notification filed by Ssl Americas, Inc. with the FDA for Durex Synthetic Polyisoprene Male Condom.
| Device ID | K072169 |
| 510k Number | K072169 |
| Device Name: | DUREX SYNTHETIC POLYISOPRENE MALE CONDOM |
| Classification | Condom, Synthetic |
| Applicant | SSL AMERICAS, INC. 3585 ENGINEERING DR. SUITE 200 Norcross, GA 30092 |
| Contact | Chris Robinson |
| Correspondent | Chris Robinson SSL AMERICAS, INC. 3585 ENGINEERING DR. SUITE 200 Norcross, GA 30092 |
| Product Code | MOL |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-06 |
| Decision Date | 2008-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10302340894576 | K072169 | 000 |
| 10302340894569 | K072169 | 000 |
| 20302340894559 | K072169 | 000 |
| 20302340908058 | K072169 | 000 |
| 00302340894562 | K072169 | 000 |