The following data is part of a premarket notification filed by Von Zeppelin Chirurgische Instrumente Gmbh with the FDA for Zeppelin Motor Drill System.
Device ID | K922299 |
510k Number | K922299 |
Device Name: | ZEPPELIN MOTOR DRILL SYSTEM |
Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
Applicant | VON ZEPPELIN CHIRURGISCHE INSTRUMENTE GMBH GISTLSTRABE 99 D-8023 PULLACH Germany, DE |
Contact | Von Zeppelin |
Correspondent | Von Zeppelin VON ZEPPELIN CHIRURGISCHE INSTRUMENTE GMBH GISTLSTRABE 99 D-8023 PULLACH Germany, DE |
Product Code | HBE |
CFR Regulation Number | 882.4310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-15 |
Decision Date | 1992-10-13 |