SENSITEX EXAMINATION GLOVE— 510(k) K981963

Substantially Equivalent

Oak Carolina, Inc.

FDA 510(k) clearance K981963 for SENSITEX EXAMINATION GLOVE, Substantially Equivalent on 1998-07-24. Applicant: Oak Carolina, Inc.. Device class: 1.

Clearance details

Applicant: Oak Carolina, Inc.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 1998-06-04
Decision date: 1998-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Travelers Rest, SC, US

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More clearances from Oak Carolina, Inc.

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Data sourced from openFDA. This site is unofficial and independent of the FDA.