Cleared Traditional

K810029 - REGULATOR VENOSET W/0.22 MICRON IVEX (FDA 510(k) Clearance)

K810029 · Abbott Laboratories · General Hospital
Jan 1981
Decision
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Days
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Risk

K810029 is an FDA 510(k) clearance for the REGULATOR VENOSET W/0.22 MICRON IVEX..

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on January 6, 1981.

This device falls under the General Hospital FDA review panel.

Submission Details

510(k) Number K810029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received January 06, 1981
Decision Date January 06, 1981
Days to Decision —
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code —
Device Class —