Cleared Traditional

SOLUTION ADMINI. SETS- ALTER. DRIP CHAMBER/CONNEC.

K870940 · Travenol Laboratories, S.A. · General Hospital
Mar 1987
Decision
8d
Days
Class 2
Risk

About This 510(k) Submission

K870940 is an FDA 510(k) clearance for the SOLUTION ADMINI. SETS- ALTER. DRIP CHAMBER/CONNEC., a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Travenol Laboratories, S.A. (Round Lake, US). The FDA issued a Cleared decision on March 17, 1987, 8 days after receiving the submission on March 9, 1987. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K870940 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 1987
Decision Date March 17, 1987
Days to Decision 8 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

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

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