510(k) K072169 ยท MOL Condom, Synthetic
DUREX SYNTHETIC POLYISOPRENE MALE CONDOM
| Applicant | Ssl Americas, Inc., Norcross GA, US |
| Decision | Substantially Equivalent, Jun 19, 2008 |
| Received | Aug 6, 2007 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K072169
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 9, 2019 | Reckitt Benckiser LLC Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14
02340-89455-00
02340-89456-14
02340-89456-14
02340-89455-00
02340-95767-00
02340-89456-14
02340-89457-00
02340-89456-14
02340-894 Terminated |
MOL | None listed |
| Mar 9, 2019 | Reckitt Benckiser LLC Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00
02340-98729-00
02340-98729-00
02340-98729-00
02340-98729-00
02340-98729-00 Terminated |
MOL | None listed |
| Aug 6, 2018 | Reckitt Benckiser LLC Polyisoprene condomns
Product Usage:
The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually t Terminated |
MOL | None listed |
| Jul 23, 2018 | Reckitt Benckiser LLC Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00
Product Usage:
The Durex Synthetic polyisoprene male condom is used for contraception and fo Terminated |
MOL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.