The following data is part of a premarket notification filed by Avalon Laboratories, Llc with the FDA for Avalon Elite Vascular Access Kit.
| Device ID | K081940 |
| 510k Number | K081940 |
| Device Name: | AVALON ELITE VASCULAR ACCESS KIT |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | AVALON LABORATORIES, LLC 2610 E. HOMESTEAD PLACE Rancho Dominguez, CA 90220 |
| Contact | Lee Wirth |
| Correspondent | Lee Wirth AVALON LABORATORIES, LLC 2610 E. HOMESTEAD PLACE Rancho Dominguez, CA 90220 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-08 |
| Decision Date | 2008-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04037691995427 | K081940 | 000 |
| 04037691995434 | K081940 | 000 |