Cleared Traditional

ANSPACH SHIELDED ATTACHMENT

K974025 · The Anspach Effort, Inc. · General & Plastic Surgery
Jul 1998
Decision
256d
Days
Class 1
Risk

About This 510(k) Submission

K974025 is an FDA 510(k) clearance for the ANSPACH SHIELDED ATTACHMENT, a Bur, Surgical, General & Plastic Surgery (Class I — General Controls, product code GFF), submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on July 6, 1998, 256 days after receiving the submission on October 23, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number K974025 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 1997
Decision Date July 06, 1998
Days to Decision 256 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code GFF — Bur, Surgical, General & Plastic Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4820

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