Cleared Traditional

DELTEC SUBCUTANEOUS INFUSION SET

K963009 · Sims Deltec, Inc. · General Hospital
Oct 1996
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K963009 is an FDA 510(k) clearance for the DELTEC SUBCUTANEOUS INFUSION SET, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Sims Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on October 18, 1996, 77 days after receiving the submission on August 2, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K963009 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 1996
Decision Date October 18, 1996
Days to Decision 77 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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