The following data is part of a premarket notification filed by New England Surgical Instrument Corp. with the FDA for Carotid Artery Clamp & Tools.
| Device ID | K811821 |
| 510k Number | K811821 |
| Device Name: | CAROTID ARTERY CLAMP & TOOLS |
| Classification | Clamp, Carotid Artery |
| Applicant | NEW ENGLAND SURGICAL INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HCE |
| CFR Regulation Number | 882.5175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-29 |
| Decision Date | 1981-09-24 |