ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS
FDA 510(k) clearance K981621 · decided 1998-06-19
Clearance details
- K-number
- K981621
- Device name
- ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS
- Applicant
- Suretex Prophylactics (India) , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1998-05-06
- Decision date
- 1998-06-19
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- LTZ
- Device class
- 2
- Regulation number
- 884.5310
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Bangalore, Karnataka, IN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LifeStyles Assorted Colors Condoms with Spermicide recall (Z-0402-03) | Ansell Healthcare Inc | 2002-12-31 |