Cleared Traditional

K941325 - WATER IRRIGATOR, W1 200
(FDA 510(k) Clearance)

K941325 · Strong Medical, Inc. · Ear, Nose, Throat device

Aug 1994

Decision

144d

Days

Class 1

Risk

K941325 is an FDA 510(k) clearance for the WATER IRRIGATOR, W1 200. This device is classified as a Stimulator, Caloric-air (Class I - General Controls, product code KHH).

Submitted by Strong Medical, Inc. (Heraklion, GR). The FDA issued a Cleared decision on August 9, 1994, 144 days after receiving the submission on March 18, 1994.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1800.

Submission Details

510(k) Number	K941325 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 18, 1994
Decision Date	August 09, 1994
Days to Decision	144 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement