510(k) K040109
K040109 is an FDA 510(k) premarket notification submitted by Tools For Surgery, LLC for the device "HEMORRHAGE OCCLUDER PIN". The FDA issued a decision of Substantially Equivalent on Mar 25, 2004. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Tools For Surgery, LLC has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 25, 2004
- Date Received
- Jan 20, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4750
- Review Panel
- SU
- Submission Type