Cleared Traditional

ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN

K122561 · Ceremed , Inc. · Ear, Nose, Throat
Nov 2012
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K122561 is an FDA 510(k) clearance for the ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN, 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 November 27, 2012, 97 days after receiving the submission on August 22, 2012. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number K122561 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2012
Decision Date November 27, 2012
Days to Decision 97 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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