The following data is part of a premarket notification filed by Hdc Corp. with the FDA for V-cath Breakaway Needle Introducer.
| Device ID | K945473 |
| 510k Number | K945473 |
| Device Name: | V-CATH BREAKAWAY NEEDLE INTRODUCER |
| Classification | Introducer, Syringe Needle |
| Applicant | HDC CORP. 2109 O'TOOLE AVE. San Jose, CA 95131 |
| Contact | Grethen Marchesani |
| Correspondent | Grethen Marchesani HDC CORP. 2109 O'TOOLE AVE. San Jose, CA 95131 |
| Product Code | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-08 |
| Decision Date | 1995-01-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B339350200 | K945473 | 000 |