Cleared Traditional

CONFIRMATION TESTS

K873907 · Richmond Products, Inc. · Ophthalmic
Dec 1987
Decision
95d
Days
Class 1
Risk

About This 510(k) Submission

K873907 is an FDA 510(k) clearance for the CONFIRMATION TESTS, a Set, Lens, Trial, Ophthalmic (Class I — General Controls, product code HPC), submitted by Richmond Products, Inc. (Boca Raton, US). The FDA issued a Cleared decision on December 29, 1987, 95 days after receiving the submission on September 25, 1987. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1405.

Submission Details

510(k) Number K873907 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 1987
Decision Date December 29, 1987
Days to Decision 95 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HPC — Set, Lens, Trial, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1405