The following data is part of a premarket notification filed by Ackermann Instrumente Gmbh with the FDA for Ackermann Europclip.
| Device ID | K111930 |
| 510k Number | K111930 |
| Device Name: | ACKERMANN EUROPCLIP |
| Classification | Clip, Implantable |
| Applicant | ACKERMANN INSTRUMENTE GMBH 8202 SHERMAN ROAD Chesterland, OH 44026 -2141 |
| Contact | Karen E Warden, Phd |
| Correspondent | Karen E Warden, Phd ACKERMANN INSTRUMENTE GMBH 8202 SHERMAN ROAD Chesterland, OH 44026 -2141 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-07 |
| Decision Date | 2011-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640140220000 | K111930 | 000 |
| 00842331115417 | K111930 | 000 |
| 00842331115424 | K111930 | 000 |
| 00842331195631 | K111930 | 000 |
| 04250302286183 | K111930 | 000 |
| 10842331118781 | K111930 | 000 |
| 10842331118798 | K111930 | 000 |
| 10842331118804 | K111930 | 000 |
| 10842331118811 | K111930 | 000 |
| 40649111341053 | K111930 | 000 |
| 40649111341220 | K111930 | 000 |
| 40649111341367 | K111930 | 000 |
| 40649111341480 | K111930 | 000 |
| 04250302249621 | K111930 | 000 |
| 04250302249614 | K111930 | 000 |
| 04250302249775 | K111930 | 000 |
| 00842331115394 | K111930 | 000 |