Cleared Traditional

NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS

K971465 · National Healthcare Mfg. Corp. · General Hospital

Jun 1997

Decision

43d

Days

Class 1

Risk

About This 510(k) Submission

K971465 is an FDA 510(k) clearance for the NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS, a Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (Class I — General Controls, product code HOY), submitted by National Healthcare Mfg. Corp. (Great Neck, US). The FDA issued a Cleared decision on June 4, 1997, 43 days after receiving the submission on April 22, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 886.4750.

Submission Details

510(k) Number	K971465 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 22, 1997
Decision Date	June 04, 1997
Days to Decision	43 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	HOY — Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
Device Class	Class I — General Controls
CFR Regulation	21 CFR 886.4750