ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS— 510(k) K983320
Substantially EquivalentSuretex Prophylactics (India) , Ltd.
FDA 510(k) clearance K983320 for ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS, Substantially Equivalent on 1998-12-11. Applicant: Suretex Prophylactics (India) , Ltd..
Clearance details
- Applicant
- Suretex Prophylactics (India) , Ltd.
- Product code
- Code HIS
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bangalore, Karnataka, IN
Data sourced from openFDA. This site is unofficial and independent of the FDA.