Cleared Traditional

ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT

K970878 · American Medical Devices, Inc. · Ophthalmic
May 1997
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K970878 is an FDA 510(k) clearance for the ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT, 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 6, 1997, 57 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 K970878 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 1997
Decision Date May 06, 1997
Days to Decision 57 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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