Cleared Traditional

ANSPACH LUBRICATING SYSTEM II

K970530 · The Anspach Effort, Inc. · General & Plastic Surgery
May 1997
Decision
82d
Days
Class 1
Risk

About This 510(k) Submission

K970530 is an FDA 510(k) clearance for the ANSPACH LUBRICATING SYSTEM II, a Motor, Surgical Instrument, Ac-powered (Class I — General Controls, product code GEY), submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on May 5, 1997, 82 days after receiving the submission on February 12, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number K970530 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 1997
Decision Date May 05, 1997
Days to Decision 82 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code GEY — Motor, Surgical Instrument, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4820

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