STERILE SILICONE EXTERNAL WOUND COVER— 510(k) K982065

Name: FDA 510(k) clearance K982065
Creator: U.S. Food and Drug Administration
Published: 1998-08-12

Substantially Equivalent

Specialty Surgical Products, Inc.

FDA 510(k) clearance K982065 for STERILE SILICONE EXTERNAL WOUND COVER, Substantially Equivalent on 1998-08-12. Applicant: Specialty Surgical Products, Inc.. Device class: 2.

Clearance details

Applicant: Specialty Surgical Products, Inc.
Product code: Code MIB
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 1998-06-12
Decision date: 1998-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamilton, MT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MIB

product code MIB

Injury: 146
Total: 146

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.