Cleared Traditional

ENDOVIEW SPPHIRE LENS SET

K971853 · American Medical Devices, Inc. · Ophthalmic
Aug 1997
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K971853 is an FDA 510(k) clearance for the ENDOVIEW SPPHIRE LENS SET, a Lens, Contact, Polymethylmethacrylate, Diagnostic (Class II — Special Controls, product code HJK), submitted by American Medical Devices, Inc. (Atlanta, US). The FDA issued a Cleared decision on August 6, 1997, 78 days after receiving the submission on May 20, 1997. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1385.

Submission Details

510(k) Number K971853 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 1997
Decision Date August 06, 1997
Days to Decision 78 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HJK — Lens, Contact, Polymethylmethacrylate, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1385

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