DUREX SYNTHETIC POLYISOPRENE MALE CONDOM
FDA 510(k) clearance K072169 · decided 2008-06-19
Clearance details
- K-number
- K072169
- Device name
- DUREX SYNTHETIC POLYISOPRENE MALE CONDOM
- Applicant
- Ssl Americas, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-08-06
- Decision date
- 2008-06-19
- Days to decision
- 318 days
- Clearance type
- Abbreviated
- Product code
- MOL
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Norcross, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 0234 recall (Z-0993-2019) | Reckitt Benckiser LLC | 2019-03-09 |
| Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00 02340-9 recall (Z-0994-2019) | Reckitt Benckiser LLC | 2019-03-09 |