Cleared Special

OCM-G1 Attachment

K180063 · The Anspach Effort, Inc. · Ear, Nose, Throat
Mar 2018
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K180063 is an FDA 510(k) clearance for the OCM-G1 Attachment, a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II — Special Controls, product code ERL), submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on March 27, 2018, 77 days after receiving the submission on January 9, 2018. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4250.

Submission Details

510(k) Number K180063 FDA.gov
FDA Decision Cleared SESE
Date Received January 09, 2018
Decision Date March 27, 2018
Days to Decision 77 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ERL — Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.4250

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