Cleared Traditional

K833741 - VENOSET MULTI MED DUAL RATE PIGGYBACK (FDA 510(k) Clearance)

Dec 1983
Decision
57d
Days
Class 2
Risk

K833741 is an FDA 510(k) clearance for the VENOSET MULTI MED DUAL RATE PIGGYBACK. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 22, 1983, 57 days after receiving the submission on October 26, 1983.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K833741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1983
Decision Date December 22, 1983
Days to Decision 57 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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