510(k) K012969
K012969 is an FDA 510(k) premarket notification submitted by Medtech Products , Ltd. for the device "DOUBLE SPRINGERS NONOXNOL 9 CONDOM". The FDA issued a decision of Substantially Equivalent on June 12, 2002. The device falls under product code LTZ (Condom With Nonoxynol-9), a Class II device regulated under 21 CFR 884.5310. Medtech Products , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 12, 2002
- Date Received
- September 4, 2001
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Condom With Nonoxynol-9
- Device Class
- Class II
- Regulation Number
- 884.5310
- Review Panel
- OB
- Submission Type