Cleared Traditional

ARTHROSCOPE

K931792 · Intramed Laboratories, Inc. · Ophthalmic
Jun 1994
Decision
427d
Days
Class 1
Risk

About This 510(k) Submission

K931792 is an FDA 510(k) clearance for the ARTHROSCOPE, a Trephine, Manual, Ophthalmic (Class I — General Controls, product code HRH), submitted by Intramed Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on June 13, 1994, 427 days after receiving the submission on April 12, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K931792 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 1993
Decision Date June 13, 1994
Days to Decision 427 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HRH — Trephine, Manual, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4350

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