510(k) K030837
K030837 is an FDA 510(k) premarket notification submitted by W.O.M. World of Medicine AG for the device "40 L HIGH FLOW INSUFFLATOR F108". The FDA issued a decision of Substantially Equivalent on February 5, 2004. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. W.O.M. World of Medicine AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 2004
- Date Received
- March 17, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Insufflator, Laparoscopic
- Device Class
- Class II
- Regulation Number
- 884.1730
- Review Panel
- OB
- Submission Type