510(k) K113061
K113061 is an FDA 510(k) premarket notification submitted by Karex Industries Sdn. Bhd. for the device "LARGE/EXTRA LAGRE CONDOM". The FDA issued a decision of Substantially Equivalent on December 7, 2011. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Karex Industries Sdn. Bhd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 2011
- Date Received
- October 14, 2011
- Clearance Type
- Special
- 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