510(k) K920044
K920044 is an FDA 510(k) premarket notification submitted by Telos Medical Corp. for the device "DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT". The FDA issued a decision of Substantially Equivalent on April 3, 1992. The device falls under product code KXO (Monitor, Pressure, Intrauterine), a Class II device regulated under 21 CFR 884.2700. Telos Medical Corp. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 1992
- Date Received
- January 6, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Pressure, Intrauterine
- Device Class
- Class II
- Regulation Number
- 884.2700
- Review Panel
- OB
- Submission Type