Cleared Traditional

K861219 - ACCUPAC CUSTOM SKIN SCRUB KIT
(FDA 510(k) Clearance)

K861219 · Geneva Laboratories, Inc. · General & Plastic Surgery device
Apr 1986
Decision
14d
Days
—
Risk

K861219 is an FDA 510(k) clearance for the ACCUPAC CUSTOM SKIN SCRUB KIT..

Submitted by Geneva Laboratories, Inc. (Elkhorn, US). The FDA issued a Cleared decision on April 15, 1986, 14 days after receiving the submission on April 1, 1986.

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

Submission Details

510(k) Number K861219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1986
Decision Date April 15, 1986
Days to Decision 14 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code —
Device Class —