Cleared Traditional

AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS

K942158 · Wfr/Aquaplast Corp. · Ear, Nose, Throat
Jul 1994
Decision
87d
Days
Class 1
Risk

About This 510(k) Submission

K942158 is an FDA 510(k) clearance for the AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS, a Splint, Nasal (Class I — General Controls, product code EPP), submitted by Wfr/Aquaplast Corp. (Wyckoff, US). The FDA issued a Cleared decision on July 29, 1994, 87 days after receiving the submission on May 3, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5800.

Submission Details

510(k) Number K942158 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 1994
Decision Date July 29, 1994
Days to Decision 87 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

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

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