The following data is part of a premarket notification filed by Von Zeppelin Gmbh with the FDA for Instruments For Neurological Surgery.
| Device ID | K901313 |
| 510k Number | K901313 |
| Device Name: | INSTRUMENTS FOR NEUROLOGICAL SURGERY |
| Classification | Rongeur, Manual |
| Applicant | VON ZEPPELIN GMBH GISTLSTRASSE 99 Pullach, DE D-82049 |
| Contact | Von Zeppelin |
| Correspondent | Von Zeppelin VON ZEPPELIN GMBH GISTLSTRASSE 99 Pullach, DE D-82049 |
| Product Code | HAE |
| CFR Regulation Number | 882.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-20 |
| Decision Date | 1990-07-23 |