510(k) K102048
K102048 is an FDA 510(k) premarket notification submitted by Geomed Medizin-Technik GmbH & Co. KG for the device "ATRAUMATIC VASCULAR CLAMPS". The FDA issued a decision of Substantially Equivalent on Nov 9, 2010. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Geomed Medizin-Technik GmbH & Co. KG has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 9, 2010
- Date Received
- Jul 21, 2010
- 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
- 510(k)