The following data is part of a premarket notification filed by Von Zeppelin Gmbh with the FDA for Intervertebral Disc Rongeur.
Device ID | K903151 |
510k Number | K903151 |
Device Name: | INTERVERTEBRAL DISC RONGEUR |
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 | 1990-07-18 |
Decision Date | 1990-12-11 |