Cleared Traditional

ADAPTAIN SOLUBLE IMPLANT MATERIAL

K120220 · Ceremed , Inc. · Ear, Nose, Throat
Jun 2012
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K120220 is an FDA 510(k) clearance for the ADAPTAIN SOLUBLE IMPLANT MATERIAL, 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 June 6, 2012, 133 days after receiving the submission on January 25, 2012. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number K120220 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2012
Decision Date June 06, 2012
Days to Decision 133 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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