Cleared Traditional

K841316 - FLATPACK CARRYING CASE (FDA 510(k) Clearance)

May 1984
Decision
44d
Days
-
Risk

K841316 is an FDA 510(k) clearance for the FLATPACK CARRYING CASE..

Submitted by Bausch & Lomb, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 16, 1984, 44 days after receiving the submission on April 2, 1984.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number K841316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1984
Decision Date May 16, 1984
Days to Decision 44 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -

Device Classification

Product Code -
Device Class -