Cleared Traditional

RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM

K963550 · Respironics, Inc. · Ear, Nose, Throat

Nov 1996

Decision

57d

Days

Class 1

Risk

About This 510(k) Submission

K963550 is an FDA 510(k) clearance for the RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM, a Irrigator, Powered Nasal (Class I — General Controls, product code KMA), submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on November 1, 1996, 57 days after receiving the submission on September 5, 1996. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5550.

Submission Details

510(k) Number	K963550 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 05, 1996
Decision Date	November 01, 1996
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF