The following data is part of a premarket notification filed by Ssl Americas, Inc. with the FDA for Durex Spearmint Scented Lubricated Latex Condom (durex 'tingling Pleasure' Condom.
Device ID | K042470 |
510k Number | K042470 |
Device Name: | DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOM |
Classification | Condom |
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 | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2004-09-13 |
Decision Date | 2005-04-05 |
Summary: | summary |