DeviceClearance

PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND— 510(k) K030813

Substantially Equivalent

Primary Care Solutions, Inc.

FDA 510(k) clearance K030813 for PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND, Substantially Equivalent on 2003-05-30. Applicant: Primary Care Solutions, Inc.. Device class: 2.

Clearance details

Applicant
Primary Care Solutions, Inc.
Product code
Code EZL
Device class
Class 2
Regulation
21 CFR 876.5130
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Zephyrhills, FL, US
Download summary PDFView on FDA.gov ↗

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More clearances from Primary Care Solutions, Inc.

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Adverse events under product code EZL

product code EZL
Death
6
Injury
796
Malfunction
4,989
Other
1
Total
5,792

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K030813

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030813.

Data sourced from openFDA. This site is unofficial and independent of the FDA.