510(k) K896390
- Device
- WILSON-COOK ESOPHAGEAL PROSTHESIS
- Applicant
- WILSON-COOK MEDICAL, INC.
- 510(k) number
- K896390
- Product code
- JCQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-12-27
- Date received
- 1989-11-06
- Regulation
- 878.3610
- Classification name
- Prosthesis, Esophagus
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD F MARSHALL
- Address
- 4900 Bethania Station Rd. & 5951 Grassy Creek Blvd. Winston-Salem NC US 27105 27105
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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