Cleared Traditional

K861308 - ACCUPAC CUSTOM PACK KERLIX SQUARES
(FDA 510(k) Clearance)

K861308 · Geneva Laboratories, Inc. · General & Plastic Surgery

May 1986

Decision

24d

Days

—

Risk

K861308 is an FDA 510(k) clearance for the ACCUPAC CUSTOM PACK KERLIX SQUARES. This device is classified as a Gauze/sponge, Internal.

Submitted by Geneva Laboratories, Inc. (Elkhorn, US). The FDA issued a Cleared decision on May 2, 1986, 24 days after receiving the submission on April 8, 1986.

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

Submission Details

510(k) Number	K861308 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 08, 1986
Decision Date	May 02, 1986
Days to Decision	24 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—