510(k) K896472
- Device
- KEY VASCULAR BOOTIES
- Applicant
- KEY SURGICAL, INC.
- 510(k) number
- K896472
- Product code
- MAW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-12-14
- Date received
- 1989-11-13
- Regulation
- 510(k) Premarket Notification
- Classification name
- Marker, Suture Identification
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAY NORDBYE
- Address
- 7101 York Ave. S. Minneapolis MN US 55435 55435
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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