The following data is part of a premarket notification filed by Clarus Medical Systems, Inc. with the FDA for Clarus Phoenix Endoscope.
Device ID | K940144 |
510k Number | K940144 |
Device Name: | CLARUS PHOENIX ENDOSCOPE |
Classification | Arthroscope |
Applicant | CLARUS MEDICAL SYSTEMS, INC. 1000 BOONE AVENUE NORTH #100 Minneapolis, MN 55427 -8656 |
Contact | Gregory J Mathison |
Correspondent | Gregory J Mathison CLARUS MEDICAL SYSTEMS, INC. 1000 BOONE AVENUE NORTH #100 Minneapolis, MN 55427 -8656 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-11 |
Decision Date | 1995-04-25 |