510(k) K890021
- Device
- STERILE POLYHESIVE PBS DRESSING
- Applicant
- VALLEYLAB, INC.
- 510(k) number
- K890021
- Product code
- KGF
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1989-06-01
- Date received
- 1989-01-04
- Regulation
- 510(k) Premarket Notification
- Classification name
- Adhesive, Tissue For Aneurysmorrhaphy
- 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
- Neurology
- Device class
- 3
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- PEGGY WALLINE
- Address
- 5920 Longbow Dr. Boulder CO US 80301 80301
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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