Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K040424 |
Device Name |
LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120 |
Applicant |
CLARUS MEDICAL, LLC. |
1000 BOONE AVE. NORTH |
MINNEAPOLIS,
MN
55427
|
|
Applicant Contact |
TOM BARTHEL |
Correspondent |
CLARUS MEDICAL, LLC. |
1000 BOONE AVE. NORTH |
MINNEAPOLIS,
MN
55427
|
|
Correspondent Contact |
TOM BARTHEL |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 02/18/2004 |
Decision Date | 05/11/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|