PRIMATRIX DERMAL REPAIR SCAFFOLD— 510(k) K083440

Substantially Equivalent

Tei Biosciences, Inc.

FDA 510(k) clearance K083440 for PRIMATRIX DERMAL REPAIR SCAFFOLD, Substantially Equivalent on 2008-12-12. Applicant: Tei Biosciences, Inc..

Clearance details

Applicant: Tei Biosciences, Inc.
Product code: Code KGN
Advisory panel: Unknown
Date received: 2008-11-20
Decision date: 2008-12-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Boston, MA, US

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Adverse events under product code KGN

product code KGN

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.