Cleared Traditional

SURGICAL HEADLIGHT

K842515 · Good-Lite Co. · Dental

Aug 1984

Decision

51d

Days

Class 1

Risk

About This 510(k) Submission

K842515 is an FDA 510(k) clearance for the SURGICAL HEADLIGHT, a Light, Surgical Headlight (Class I — General Controls, product code EBA), submitted by Good-Lite Co. (Mchenry, US). The FDA issued a Cleared decision on August 2, 1984, 51 days after receiving the submission on June 12, 1984. This device falls under the Dental review panel. Regulated under 21 CFR 872.4630.

Submission Details

510(k) Number	K842515 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 12, 1984
Decision Date	August 02, 1984
Days to Decision	51 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—