Cleared Traditional

HOOD NASAL SPLINT

K890599 · Hood Laboratories · Ear, Nose, Throat
Mar 1989
Decision
39d
Days
Class 1
Risk

About This 510(k) Submission

K890599 is an FDA 510(k) clearance for the HOOD NASAL SPLINT, a Splint, Nasal (Class I — General Controls, product code EPP), submitted by Hood Laboratories (Pembroke, US). The FDA issued a Cleared decision on March 17, 1989, 39 days after receiving the submission on February 6, 1989. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5800.

Submission Details

510(k) Number K890599 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 1989
Decision Date March 17, 1989
Days to Decision 39 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

Product Code EPP — Splint, Nasal
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.5800

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