OPPORTUNITY, INC. LACERATION TRAY— 510(k) K971089

Name: FDA 510(k) clearance K971089
Creator: U.S. Food and Drug Administration
Published: 1997-09-16

Substantially Equivalent for Some Indications

Opportunity, Inc.

FDA 510(k) clearance K971089 for OPPORTUNITY, INC. LACERATION TRAY, Substantially Equivalent for Some Indications on 1997-09-16. Applicant: Opportunity, Inc.. Device class: 2.

Clearance details

Applicant: Opportunity, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1997-03-24
Decision date: 1997-09-16
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Highland Park, IL, US

Download summary PDF View on FDA.gov ↗

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