Cleared Traditional

HEAD & CHIN RESTS

K873918 · Richmond Products, Inc. · Ophthalmic
Oct 1987
Decision
34d
Days
Class 1
Risk

About This 510(k) Submission

K873918 is an FDA 510(k) clearance for the HEAD & CHIN RESTS, a Trephine, Manual, Ophthalmic (Class I — General Controls, product code HRH), submitted by Richmond Products, Inc. (Boca Raton, US). The FDA issued a Cleared decision on October 28, 1987, 34 days after receiving the submission on September 24, 1987. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K873918 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 1987
Decision Date October 28, 1987
Days to Decision 34 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

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

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