510(k) K811821
- Device
- CAROTID ARTERY CLAMP & TOOLS
- Applicant
- NEW ENGLAND SURGICAL INSTRUMENT CORP.
- 510(k) number
- K811821
- Product code
- HCE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-09-24
- Date received
- 1981-06-29
- Regulation
- 882.5175
- Classification name
- Clamp, Carotid Artery
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1522875
- 1219619
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HCE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K870399 | SELVERSTONE CLAMP SALIBI CLAMP | Codman & Shurtleff, Inc. | 1987-03-06 |
Legacy Summary#
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FDA Review#
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