RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE— 510(k) K113839

Name: FDA 510(k) clearance K113839
Creator: U.S. Food and Drug Administration
Published: 2012-04-12

Substantially Equivalent

Parkell, Inc.

FDA 510(k) clearance K113839 for RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE, Substantially Equivalent on 2012-04-12. Applicant: Parkell, Inc.. Device class: Unclassified.

Clearance details

Applicant: Parkell, Inc.
Product code: Product code MVL
Device class: Unclassified
Advisory panel: Unknown
Date received: 2011-12-28
Decision date: 2012-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edgewood, NY, 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.