OPPORTUNITY INC. GENERAL PURPOSE TRAY— 510(k) K971062

Substantially Equivalent for Some Indications

Opportunity, Inc.

FDA 510(k) clearance K971062 for OPPORTUNITY INC. GENERAL PURPOSE TRAY, Substantially Equivalent for Some Indications on 1997-06-09. Applicant: Opportunity, Inc..

Clearance details

Applicant: Opportunity, Inc.
Product code: Code LRO
Advisory panel: General, Plastic Surgery
Date received: 1997-03-24
Decision date: 1997-06-09
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Highland Park, IL, US

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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.