OPPURTUNITY TRACHEOSTOMY CARE KIT— 510(k) K971091

Name: FDA 510(k) clearance K971091
Creator: U.S. Food and Drug Administration
Published: 1997-09-16

Substantially Equivalent for Some Indications

Opportunity, Inc.

FDA 510(k) clearance K971091 for OPPURTUNITY TRACHEOSTOMY CARE KIT, Substantially Equivalent for Some Indications on 1997-09-16. Applicant: Opportunity, Inc.. Device class: 1.

Clearance details

Applicant: Opportunity, Inc.
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
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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