Cleared Traditional

K863662 - OPHTHALMIC SURGICAL DRAPE
(FDA 510(k) Clearance)

Oct 1986
Decision
32d
Days
Risk

K863662 is an FDA 510(k) clearance for the OPHTHALMIC SURGICAL DRAPE..

Submitted by Myocure, Inc. (Glendale, US). The FDA issued a Cleared decision on October 20, 1986, 32 days after receiving the submission on September 18, 1986.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number K863662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1986
Decision Date October 20, 1986
Days to Decision 32 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

Device Classification

Product Code
Device Class