Cleared Traditional

ANSPACH ADVANCED MICRO SAW ATTACHMENTS

K040076 · The Anspach Effort, Inc. · Neurology
Mar 2004
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K040076 is an FDA 510(k) clearance for the ANSPACH ADVANCED MICRO SAW ATTACHMENTS, a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II — Special Controls, product code HBE), submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on March 15, 2004, 61 days after receiving the submission on January 14, 2004. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K040076 FDA.gov
FDA Decision Cleared SESE
Date Received January 14, 2004
Decision Date March 15, 2004
Days to Decision 61 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBE — Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4310

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