ISOSEED
Source, Brachytherapy, Radionuclide
ECKERT & ZIEGLER BEBIG GMBH
The following data is part of a premarket notification filed by Eckert & Ziegler Bebig Gmbh with the FDA for Isoseed.
Pre-market Notification Details
| Device ID | K140849 |
| 510k Number | K140849 |
| Device Name: | ISOSEED |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | ECKERT & ZIEGLER BEBIG GMBH ROBERT-ROSSLE STR.10 Berlin, DE 13125 |
| Contact | Sven Langer |
| Correspondent | Sven Langer ECKERT & ZIEGLER BEBIG GMBH ROBERT-ROSSLE STR.10 Berlin, DE 13125 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-03 |
| Decision Date | 2014-07-02 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049223117184 | K140849 | 000 |
Trademark Results [ISOSEED]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ISOSEED 77897986 3885169 Dead/Cancelled |
Eckert & Ziegler BEBIG GmbH 2009-12-21 |
 ISOSEED 75562061 2411202 Dead/Cancelled |
ISO-SCIENCE LABORATORIES, INC. 1998-09-30 |
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