The following data is part of a premarket notification filed by Itl Corporation, Pty Ltd. with the FDA for Platypus Av Fistula Needle Protector (avfnp).
| Device ID | K991404 |
| 510k Number | K991404 |
| Device Name: | PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP) |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | ITL CORPORATION, PTY LTD. 15825 SHADY GROVE RD. SUITE 90 Rockville, MD 20850 |
| Contact | Kenneth A Palmer |
| Correspondent | Kenneth A Palmer ITL CORPORATION, PTY LTD. 15825 SHADY GROVE RD. SUITE 90 Rockville, MD 20850 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-22 |
| Decision Date | 1999-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 19555240400168 | K991404 | 000 |