510(k) K052059
K052059 is an FDA 510(k) premarket notification submitted by Inntec, Inc. for the device "IUI CATHETER, MODEL 9057". The FDA issued a decision of Substantially Equivalent on November 22, 2005. The device falls under product code MQF (Catheter, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6110. Inntec, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2005
- Date Received
- July 29, 2005
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6110
- Review Panel
- OB
- Submission Type