Cleared Traditional

K850649 - ABSORBABLE INTRACANALICULAR COLLAGEN IMPLANT
(FDA 510(k) Clearance)

K850649 · Lacrimedics, Inc. · Ophthalmic device
May 1985
Decision
91d
Days
—
Risk

K850649 is an FDA 510(k) clearance for the ABSORBABLE INTRACANALICULAR COLLAGEN IMPLANT..

Submitted by Lacrimedics, Inc. (San Marino, US). The FDA issued a Cleared decision on May 21, 1985, 91 days after receiving the submission on February 19, 1985.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number K850649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1985
Decision Date May 21, 1985
Days to Decision 91 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code —
Device Class —