510(k) K983320
K983320 is an FDA 510(k) premarket notification submitted by Suretex Prophylactics (India) , Ltd. for the device "ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS". The FDA issued a decision of Substantially Equivalent on December 11, 1998. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Suretex Prophylactics (India) , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 1998
- Date Received
- September 21, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Condom
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type