The following data is part of a premarket notification filed by Infucare Products, Inc. with the FDA for Vascular Access Port Huber Point Infusion Needles.
| Device ID | K884792 |
| 510k Number | K884792 |
| Device Name: | VASCULAR ACCESS PORT HUBER POINT INFUSION NEEDLES |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | INFUCARE PRODUCTS, INC. 917 KLOSTERMAN RD.E Tarpon Springs, FL 34689 |
| Contact | Joseph E Harms |
| Correspondent | Joseph E Harms INFUCARE PRODUCTS, INC. 917 KLOSTERMAN RD.E Tarpon Springs, FL 34689 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-15 |
| Decision Date | 1989-01-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20809160074142 | K884792 | 000 |
| 20809160074036 | K884792 | 000 |
| 20809160055516 | K884792 | 000 |
| 20809160317300 | K884792 | 000 |