POROUS, BREATHING TAPE W/RELEASE LINER— 510(k) K802752

Substantially Equivalent

Bioadhesive Systems, Inc.

FDA 510(k) clearance K802752 for POROUS, BREATHING TAPE W/RELEASE LINER, Substantially Equivalent on 1980-12-10. Applicant: Bioadhesive Systems, Inc..

Clearance details

Applicant: Bioadhesive Systems, Inc.
Product code: Code KGX
Advisory panel: General Hospital
Date received: 1980-11-03
Decision date: 1980-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KGX

product code KGX

Injury: 1,590
Malfunction: 1,357
Other: 3
Total: 2,950

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.