510(k) K041094
K041094 is an FDA 510(k) premarket notification submitted by Bioteque America, Inc. for the device "HSG CATHETER SET". The FDA issued a decision of Substantially Equivalent on June 17, 2004. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. Bioteque America, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 2004
- Date Received
- April 27, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Cannula, Manipulator/Injector, Uterine
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type