The following data is part of a premarket notification filed by Clarus Medical Systems, Inc. with the FDA for Clarus Endoscopic Ball Probe.
Device ID | K926048 |
510k Number | K926048 |
Device Name: | CLARUS ENDOSCOPIC BALL PROBE |
Classification | Instrument, Microsurgical |
Applicant | CLARUS MEDICAL SYSTEMS, INC. 2605 FERNBROOK LA Minneapolis, MN 55447 |
Contact | Gregory J Mathison |
Correspondent | Gregory J Mathison CLARUS MEDICAL SYSTEMS, INC. 2605 FERNBROOK LA Minneapolis, MN 55447 |
Product Code | GZX |
CFR Regulation Number | 882.4525 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-01 |
Decision Date | 1993-04-07 |