Cleared Traditional

DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS

K953012 · Boston Surgical Products, Inc. · General & Plastic Surgery
Jul 1995
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K953012 is an FDA 510(k) clearance for the DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS, a Blade, Saw, General & Plastic Surgery, Surgical (Class I — General Controls, product code GFA), submitted by Boston Surgical Products, Inc. (Kingston, US). The FDA issued a Cleared decision on July 12, 1995, 14 days after receiving the submission on June 28, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number K953012 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 1995
Decision Date July 12, 1995
Days to Decision 14 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GFA — Blade, Saw, General & Plastic Surgery, Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4820

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