BIOBRANE(R) II— 510(k) K896110

Name: FDA 510(k) clearance K896110
Creator: U.S. Food and Drug Administration
Published: 1989-11-28

Substantially Equivalent

Sterling Drug, Inc.

FDA 510(k) clearance K896110 for BIOBRANE(R) II, Substantially Equivalent on 1989-11-28. Applicant: Sterling Drug, Inc.. Device class: Unclassified.

Clearance details

Applicant: Sterling Drug, Inc.
Product code: Code KGN
Device class: Unclassified
Advisory panel: Unknown
Date received: 1989-10-23
Decision date: 1989-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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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.