MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM)— 510(k) K874480

Substantially Equivalent for Some Indications

Omikron Scientific, Ltd.

FDA 510(k) clearance K874480 for MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM), Substantially Equivalent for Some Indications on 1988-02-22. Applicant: Omikron Scientific, Ltd..

Clearance details

Applicant: Omikron Scientific, Ltd.
Product code: Code NAD
Advisory panel: General, Plastic Surgery
Date received: 1987-11-02
Decision date: 1988-02-22
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Israel, IL

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Adverse events under product code NAD

product code NAD

Injury: 431
Malfunction: 11,935
Other: 1
Total: 12,367

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.