Cleared Traditional

GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR

K952569 · Gamp & Assoc. · Ophthalmic
Jan 1996
Decision
214d
Days
Class 2
Risk

About This 510(k) Submission

K952569 is an FDA 510(k) clearance for the GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR, a Apparatus, Cautery, Radiofrequency, Ac-powered (Class II — Special Controls, product code HQR), submitted by Gamp & Assoc. (Bridgeton, US). The FDA issued a Cleared decision on January 5, 1996, 214 days after receiving the submission on June 5, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4100.

Submission Details

510(k) Number K952569 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 1995
Decision Date January 05, 1996
Days to Decision 214 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HQR — Apparatus, Cautery, Radiofrequency, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4100

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