The following data is part of a premarket notification filed by Clarus Medical Systems, Inc. with the FDA for Percscope Model 2600.
Device ID | K974579 |
510k Number | K974579 |
Device Name: | PERCSCOPE MODEL 2600 |
Classification | Arthroscope |
Applicant | CLARUS MEDICAL SYSTEMS, INC. 1000 BOONE AVENUE NORTH #100 Minneapolis, MN 55427 -8656 |
Contact | Dale Sappenfield |
Correspondent | Dale Sappenfield 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 | 1997-12-08 |
Decision Date | 1998-02-18 |
Summary: | summary |