Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K994010 |
Device Name |
INNOVAQUARTZ GENERAL SHAPE LASER FIBER |
Applicant |
INNOVAQUARTZ |
4420 SOUTH 32ND ST. |
PHOENIX,
AZ
85040
|
|
Applicant Contact |
RANDY MCLELLAN |
Correspondent |
INNOVAQUARTZ |
4420 SOUTH 32ND ST. |
PHOENIX,
AZ
85040
|
|
Correspondent Contact |
RANDY MCLELLAN |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 11/26/1999 |
Decision Date | 12/17/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|