510(k) K032227
K032227 is an FDA 510(k) premarket notification submitted by Ssl Americas, Inc. for the device "DUREX FLAVORED LATEX CONDOM". The FDA issued a decision of Substantially Equivalent on March 29, 2004. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Ssl Americas, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 29, 2004
- Date Received
- July 21, 2003
- Clearance Type
- Abbreviated
- 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