510(k) K111093
K111093 is an FDA 510(k) premarket notification submitted by Mapa GmbH for the device "BILLY BOY MALE LATEX CONDOM". The FDA issued a decision of Substantially Equivalent on Jun 3, 2011. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Mapa GmbH has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 3, 2011
- Date Received
- Apr 19, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device classification
- Device Name
- Condom
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type
- 510(k)