ACCU-CHEK LINKASSIST
Introducer, Syringe Needle
DISETRONIC MEDICAL SYSTEMS AG
The following data is part of a premarket notification filed by Disetronic Medical Systems Ag with the FDA for Accu-chek Linkassist.
Pre-market Notification Details
| Device ID | K063146 |
| 510k Number | K063146 |
| Device Name: | ACCU-CHEK LINKASSIST |
| Classification | Introducer, Syringe Needle |
| Applicant | DISETRONIC MEDICAL SYSTEMS AG 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Scott Thiel |
| Correspondent | Scott Thiel DISETRONIC MEDICAL SYSTEMS AG 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-16 |
| Decision Date | 2006-11-27 |
| Summary: | summary |
Trademark Results [ACCU-CHEK LINKASSIST]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCU-CHEK LINKASSIST 79020212 3202402 Live/Registered |
Roche Diabetes Care GmbH 2005-09-09 |
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