Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K022464 |
Device Name |
EQUILASE SYSTEM |
Applicant |
EQUILASERS, INC |
3350 SCOTT BLVD. |
UNIT 5 |
SANTA CLARA,
CA
95054
|
|
Applicant Contact |
RICHARD C SAM |
Correspondent |
EQUILASERS, INC |
3350 SCOTT BLVD. |
UNIT 5 |
SANTA CLARA,
CA
95054
|
|
Correspondent Contact |
RICHARD C SAM |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 07/26/2002 |
Decision Date | 11/21/2002 |
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
|