Cleared Traditional

PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION

K000266 · Primary Care Solutions, Inc. · General Hospital
Jul 2001
Decision
531d
Days
Class 2
Risk

About This 510(k) Submission

K000266 is an FDA 510(k) clearance for the PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION, a Catheter And Tip, Suction (Class II — Special Controls, product code JOL), submitted by Primary Care Solutions, Inc. (Ringwood, US). The FDA issued a Cleared decision on July 12, 2001, 531 days after receiving the submission on January 28, 2000. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K000266 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 2000
Decision Date July 12, 2001
Days to Decision 531 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code JOL — Catheter And Tip, Suction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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