The following data is part of a premarket notification filed by Vitalcare Group, Inc. with the FDA for Vitalcare Sterilewater And 0.9% Sodium Chloride Pre-filled 10cc/30cc Syringes.
| Device ID | K031748 |
| 510k Number | K031748 |
| Device Name: | VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | VITALCARE GROUP, INC. 8935 N.W. 27TH ST. Miami, FL 33172 |
| Contact | Michael Mcavenia |
| Correspondent | Michael Mcavenia VITALCARE GROUP, INC. 8935 N.W. 27TH ST. Miami, FL 33172 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-05 |
| Decision Date | 2003-08-27 |
| Summary: | summary |