510(k) K012041
K012041 is an FDA 510(k) premarket notification submitted by Tenacore Holdings, Inc. for the device "THE HAMMER MODEL H100". The FDA issued a decision of Substantially Equivalent on March 28, 2002. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Tenacore Holdings, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 2002
- Date Received
- June 29, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Vascular
- Device Class
- Class II
- Regulation Number
- 870.4450
- Review Panel
- CV
- Submission Type