GELSPRAY WOUND DRESSING— 510(k) K073663

Substantially Equivalent

Biocure, Inc.

FDA 510(k) clearance K073663 for GELSPRAY WOUND DRESSING, Substantially Equivalent on 2008-01-30. Applicant: Biocure, Inc.. Device class: 1.

Clearance details

Applicant: Biocure, Inc.
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 2007-12-26
Decision date: 2008-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South West Ranches, FL, US

Download summary PDF View on FDA.gov ↗

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