The following data is part of a premarket notification filed by Ssl Americas, Inc. with the FDA for Durex Flavored Latex Condom.
| Device ID | K032227 |
| 510k Number | K032227 |
| Device Name: | DUREX FLAVORED LATEX CONDOM |
| Classification | Condom |
| Applicant | SSL AMERICAS, INC. 3585 ENGINEERING DR. SUITE 200 Norcross, GA 30092 |
| Contact | Kathleen Harris |
| Correspondent | Kathleen Harris SSL AMERICAS, INC. 3585 ENGINEERING DR. SUITE 200 Norcross, GA 30092 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-21 |
| Decision Date | 2004-03-29 |
| Summary: | summary |