Cleared Traditional

K853265 - ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543
(FDA 510(k) Clearance)

K853265 · Geneva Laboratories, Inc. · General & Plastic Surgery device
Aug 1985
Decision
21d
Days
—
Risk

K853265 is an FDA 510(k) clearance for the ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543..

Submitted by Geneva Laboratories, Inc. (Elkhorn, US). The FDA issued a Cleared decision on August 26, 1985, 21 days after receiving the submission on August 5, 1985.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K853265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1985
Decision Date August 26, 1985
Days to Decision 21 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code —
Device Class —