TOPICAL APPLICATOR— 510(k) K070596

Substantially Equivalent

Sharn, Inc.

FDA 510(k) clearance K070596 for TOPICAL APPLICATOR, Substantially Equivalent on 2007-06-21. Applicant: Sharn, Inc..

Clearance details

Applicant: Sharn, Inc.
Product code: Code CCT
Advisory panel: Anesthesiology
Date received: 2007-03-02
Decision date: 2007-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

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Adverse events under product code CCT

product code CCT

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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