Cleared Traditional

FIBER HEAD LIGHT FH-300

K951337 · Neitz Instruments Company, Ltd. · Ophthalmic

Jun 1995

Decision

76d

Days

Class 2

Risk

About This 510(k) Submission

K951337 is an FDA 510(k) clearance for the FIBER HEAD LIGHT FH-300, a Headlamp, Operating, Ac-powered (Class II — Special Controls, product code HPQ), submitted by Neitz Instruments Company, Ltd. (Tokyo, JP). The FDA issued a Cleared decision on June 8, 1995, 76 days after receiving the submission on March 24, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4335.

Submission Details

510(k) Number	K951337 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 24, 1995
Decision Date	June 08, 1995
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement