510(k) K091519
K091519 is an FDA 510(k) premarket notification submitted by Haemoband Surgical, Ltd. for the device "HAEMOBAND MULTI-LIGATOR". The FDA issued a decision of Substantially Equivalent on July 28, 2009. The device falls under product code FHN (Ligator, Hemorrhoidal), a Class II device regulated under 21 CFR 876.4400. Haemoband Surgical, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 2009
- Date Received
- May 22, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ligator, Hemorrhoidal
- Device Class
- Class II
- Regulation Number
- 876.4400
- Review Panel
- GU
- Submission Type