Cleared Traditional

PIV SYSTEM

K981032 · Medical Solutions, Inc. · General & Plastic Surgery
Sep 1998
Decision
167d
Days
Risk

About This 510(k) Submission

K981032 is an FDA 510(k) clearance for the PIV SYSTEM, submitted by Medical Solutions, Inc. (Crofton, US). The FDA issued a Cleared decision on September 2, 1998, 167 days after receiving the submission on March 19, 1998. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K981032 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 1998
Decision Date September 02, 1998
Days to Decision 167 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code LDQ
Device Class