510(k) K040148
K040148 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "RESOLUTION HEMOSTASIS CLIPPING DEVICE". The FDA issued a decision of Substantially Equivalent on April 22, 2004. The device falls under product code MCH (Clip, Hemostatic), a Class II device regulated under 21 CFR 878.4300. Boston Scientific Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 22, 2004
- Date Received
- January 23, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Hemostatic
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type