510(k) K870399
K870399 is an FDA 510(k) premarket notification submitted by Codman & Shurtleff, Inc. for the device "SELVERSTONE CLAMP SALIBI CLAMP". The FDA issued a decision of Substantially Equivalent on March 6, 1987. The device falls under product code HCE (Clamp, Carotid Artery), a Class II device regulated under 21 CFR 882.5175. Codman & Shurtleff, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 6, 1987
- Date Received
- February 2, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Carotid Artery
- Device Class
- Class II
- Regulation Number
- 882.5175
- Review Panel
- NE
- Submission Type