Cleared Traditional

K791104 - B & L OPHTHALMIC INSTRUMENT STAND (FDA 510(k) Clearance)

Jul 1979
Decision
41d
Days
Class 1
Risk

K791104 is an FDA 510(k) clearance for the B & L OPHTHALMIC INSTRUMENT STAND. This device is classified as a Stand, Instrument, Ac-powered, Ophthalmic (Class I - General Controls, product code HMF).

Submitted by Bausch & Lomb, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 24, 1979, 41 days after receiving the submission on June 13, 1979.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1860.

Submission Details

510(k) Number K791104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1979
Decision Date July 24, 1979
Days to Decision 41 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -

Device Classification

Product Code HMF - Stand, Instrument, Ac-powered, Ophthalmic
Device Class Class I - General Controls
CFR Regulation 21 CFR 886.1860