Cleared Traditional

ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI

K132198 · Ceremed , Inc. · Ear, Nose, Throat
Sep 2013
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K132198 is an FDA 510(k) clearance for the ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI, a Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) (Class II — Special Controls, product code KHJ), submitted by Ceremed , Inc. (Los Angeles, US). The FDA issued a Cleared decision on September 12, 2013, 58 days after receiving the submission on July 16, 2013. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number K132198 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2013
Decision Date September 12, 2013
Days to Decision 58 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code KHJ — Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3620

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