Cleared Traditional

K883984 - HEMORX COLD PACK (FDA 510(k) Clearance)

K883984 · Bio-Dyne, Inc. · Gastroenterology & Urology device

Dec 1988

Decision

93d

Days

—

Risk

K883984 is an FDA 510(k) clearance for the HEMORX COLD PACK. This device is classified as a Device, Thermal, Hemorrhoids.

Submitted by Bio-Dyne, Inc. (Miami, US). The FDA issued a Cleared decision on December 22, 1988, 93 days after receiving the submission on September 20, 1988.

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

Submission Details

510(k) Number	K883984 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 20, 1988
Decision Date	December 22, 1988
Days to Decision	93 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—