Cleared Traditional

CORRECT FLO

K851299 · Norton Performance Plastics Corp. · General Hospital
May 1985
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K851299 is an FDA 510(k) clearance for the CORRECT FLO, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Norton Performance Plastics Corp. (Akron, US). The FDA issued a Cleared decision on May 7, 1985, 36 days after receiving the submission on April 1, 1985. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K851299 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 1985
Decision Date May 07, 1985
Days to Decision 36 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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