510(k) K870399
- Device
- SELVERSTONE CLAMP SALIBI CLAMP
- Applicant
- Codman & Shurtleff, Inc.
- 510(k) number
- K870399
- Product code
- HCE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-03-06
- Date received
- 1987-02-02
- 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#
- Contact
- DONALD A LINCOLN
- Address
- 41 Pacella Park Dr. Randolph Industrial Park Randolph MA US 02368 02368
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 |
|---|---|---|---|
| K811821 | CAROTID ARTERY CLAMP & TOOLS | New England Surgical Instrument Corp. | 1981-09-24 |
Legacy Summary#
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FDA Review#
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