Cleared Traditional

HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS

K822272 · Kelleher Corp. · Ophthalmic

Nov 1982

Decision

104d

Days

Class 2

Risk

About This 510(k) Submission

K822272 is an FDA 510(k) clearance for the HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS, a Headlamp, Operating, Ac-powered (Class II — Special Controls, product code HPQ), submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on November 10, 1982, 104 days after receiving the submission on July 29, 1982. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4335.

Submission Details

510(k) Number	K822272 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 29, 1982
Decision Date	November 10, 1982
Days to Decision	104 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—