GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II— 510(k) K901369

Substantially Equivalent

Sterling Drug, Inc.

FDA 510(k) clearance K901369 for GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II, Substantially Equivalent on 1990-06-05. Applicant: Sterling Drug, Inc..

Clearance details

Applicant: Sterling Drug, Inc.
Product code: Code KGN
Advisory panel: Unknown
Date received: 1990-03-23
Decision date: 1990-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, 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.