Cleared Traditional

ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)

K970875 · American Medical Devices, Inc. · Ophthalmic
May 1997
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K970875 is an FDA 510(k) clearance for the ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.), a Endoilluminator (Class II — Special Controls, product code MPA), submitted by American Medical Devices, Inc. (Atlanta, US). The FDA issued a Cleared decision on May 20, 1997, 71 days after receiving the submission on March 10, 1997. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K970875 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 1997
Decision Date May 20, 1997
Days to Decision 71 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MPA — Endoilluminator
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500

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