The following data is part of a premarket notification filed by Platinum Services, Inc. with the FDA for Seragard Vascular Access Patch.
| Device ID | K001175 |
| 510k Number | K001175 |
| Device Name: | SERAGARD VASCULAR ACCESS PATCH |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | PLATINUM SERVICES, INC. 115 BOISE ST. Dequincy, LA 70633 |
| Contact | Nancy Y Street |
| Correspondent | Nancy Y Street PLATINUM SERVICES, INC. 115 BOISE ST. Dequincy, LA 70633 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-11 |
| Decision Date | 2000-09-18 |