The following data is part of a premarket notification filed by Ovesco Endoscopy Ag with the FDA for Endo-maryland Dissector.
| Device ID | K141794 |
| 510k Number | K141794 |
| Device Name: | ENDO-MARYLAND DISSECTOR |
| Classification | Forceps, Biopsy, Electric |
| Applicant | OVESCO ENDOSCOPY AG DORFACKERSTRASSE 26 Tuebingen, Baden-wuerttemberg, DE 72074 |
| Contact | Tanja R Linzer |
| Correspondent | Tanja R Linzer OVESCO ENDOSCOPY AG DORFACKERSTRASSE 26 Tuebingen, Baden-wuerttemberg, DE 72074 |
| Product Code | KGE |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-02 |
| Decision Date | 2014-11-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260206310341 | K141794 | 000 |