510(k) K911915
K911915 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "HEMOCLIP II". The FDA issued a decision of Substantially Equivalent on January 9, 1992. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. Edward Weck, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 1992
- Date Received
- April 30, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type