PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND

Catheter, Retention Type, Balloon

PRIMARY CARE SOLUTIONS, INC.

The following data is part of a premarket notification filed by Primary Care Solutions, Inc. with the FDA for Primary Care Solutions Prefilled 10cc And Prefilled 30cc Inflation Syringes With Sterile Water Catalog Numbers 1010 And.

Pre-market Notification Details

Device IDK030813
510k NumberK030813
Device Name:PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND
ClassificationCatheter, Retention Type, Balloon
Applicant PRIMARY CARE SOLUTIONS, INC. 40420 FREE FALL AVE. Zephyrhills,  FL  33540
ContactRon Maddix
CorrespondentRon Maddix
PRIMARY CARE SOLUTIONS, INC. 40420 FREE FALL AVE. Zephyrhills,  FL  33540
Product CodeEZL  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-14
Decision Date2003-05-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B150PT000142264 K030813 000
B15010304 K030813 000
B1501030A4 K030813 000
B150516174 K030813 000
B150516384 K030813 000
B150523324 K030813 000
B150523334 K030813 000
B150578494 K030813 000
B150578504 K030813 000
B15060244 K030813 000
B15064967224 K030813 000
B15064967234 K030813 000
B150PT000142244 K030813 000
B15010104 K030813 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.