Cleared Traditional

K042564 - HEMOR-RITE CRYOTHERAPHY (FDA 510(k) Clearance)

K042564 · Fama Holdings International Corp · Gastroenterology & Urology device

Sep 2005

Decision

374d

Days

—

Risk

K042564 is an FDA 510(k) clearance for the HEMOR-RITE CRYOTHERAPHY. This device is classified as a Device, Thermal, Hemorrhoids.

Submitted by Fama Holdings International Corp (Parkland, US). The FDA issued a Cleared decision on September 30, 2005, 374 days after receiving the submission on September 21, 2004.

This device falls under the Gastroenterology & Urology FDA review panel.

Submission Details

510(k) Number	K042564 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 21, 2004
Decision Date	September 30, 2005
Days to Decision	374 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF