510(k) K063401
K063401 is an FDA 510(k) premarket notification submitted by Medtech Products , Ltd. for the device "BANANA RIBBED". The FDA issued a decision of Substantially Equivalent on March 26, 2007. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Medtech Products , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 2007
- Date Received
- November 9, 2006
- 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