510(k) K811821
K811821 is an FDA 510(k) premarket notification submitted by New England Surgical Instrument Corp. for the device "CAROTID ARTERY CLAMP & TOOLS". The FDA issued a decision of Substantially Equivalent on September 24, 1981. The device falls under product code HCE (Clamp, Carotid Artery), a Class II device regulated under 21 CFR 882.5175. New England Surgical Instrument Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 24, 1981
- Date Received
- June 29, 1981
- 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