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.
| Device ID | K030813 |
| 510k Number | K030813 |
| Device Name: | PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | PRIMARY CARE SOLUTIONS, INC. 40420 FREE FALL AVE. Zephyrhills, FL 33540 |
| Contact | Ron Maddix |
| Correspondent | Ron Maddix PRIMARY CARE SOLUTIONS, INC. 40420 FREE FALL AVE. Zephyrhills, FL 33540 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-14 |
| Decision Date | 2003-05-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 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 |