510(k) K052642
K052642 is an FDA 510(k) premarket notification submitted by First Call, Inc. for the device "SUTURING WASHER". The FDA issued a decision of Substantially Equivalent on January 17, 2006. The device falls under product code MAB (Marker, Cardiopulmonary Bypass (Vein Marker)), a Class II device regulated under 21 CFR 870.3450.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 2006
- Date Received
- September 26, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Marker, Cardiopulmonary Bypass (Vein Marker)
- Device Class
- Class II
- Regulation Number
- 870.3450
- Review Panel
- CV
- Submission Type