LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM
FDA 510(k) clearance K000408 · decided 2000-04-19
Clearance details
- K-number
- K000408
- Device name
- LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM
- Applicant
- Suretex Prophylactics , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2000-02-08
- Decision date
- 2000-04-19
- Days to decision
- 71 days
- Clearance type
- Abbreviated
- Product code
- HIS
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Dothan, AL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra Sensitive recall (Z-0717-2013) | Ansell Healthcare Products LLC | 2013-01-24 |
| LifeStyles Assorted Colors Condoms with Spermicide recall (Z-0402-03) | Ansell Healthcare Inc | 2002-12-31 |