Cleared Traditional

ANSPACH ACCESS CRANIAL PERFORATOR

K982991 · The Anspach Effort, Inc. · Neurology
Oct 1998
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K982991 is an FDA 510(k) clearance for the ANSPACH ACCESS CRANIAL PERFORATOR, a Drills, Burrs, Trephines & Accessories (compound, Powered) (Class II — Special Controls, product code HBF), submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on October 21, 1998, 55 days after receiving the submission on August 27, 1998. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4305.

Submission Details

510(k) Number K982991 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 1998
Decision Date October 21, 1998
Days to Decision 55 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code HBF — Drills, Burrs, Trephines & Accessories (compound, Powered)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4305

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