Cleared Traditional

K043204 - SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP
(FDA 510(k) Clearance)

K043204 · Sgarlato Laboratories, Inc. · General Hospital

Mar 2005

Decision

132d

Days

Class 2

Risk

K043204 is an FDA 510(k) clearance for the SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Sgarlato Laboratories, Inc. (Campbell, US). The FDA issued a Cleared decision on March 30, 2005, 132 days after receiving the submission on November 18, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K043204 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 18, 2004
Decision Date	March 30, 2005
Days to Decision	132 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF