HOMER MAMMALOK LOCALIZATION SHIELD— 510(k) K885090

Name: FDA 510(k) clearance K885090
Creator: U.S. Food and Drug Administration
Published: 1989-02-14

Substantially Equivalent

North American Instrument Corp.

FDA 510(k) clearance K885090 for HOMER MAMMALOK LOCALIZATION SHIELD, Substantially Equivalent on 1989-02-14. Applicant: North American Instrument Corp.. Device class: 2.

Clearance details

Applicant: North American Instrument Corp.
Product code: Code LRO
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1988-12-12
Decision date: 1989-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glens Falls, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LRO

product code LRO

Injury: 975
Malfunction: 14,038
Other: 2
Total: 15,015

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.