510(k) K972745
K972745 is an FDA 510(k) premarket notification submitted by Eisner USA, Inc. for the device "TITANIUM HEMOSTATIC CLIP". The FDA issued a decision of Substantially Equivalent on October 21, 1997. The device falls under product code MCH (Clip, Hemostatic), a Class II device regulated under 21 CFR 878.4300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 1997
- Date Received
- July 23, 1997
- 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