Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K022226 |
Device Name |
ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS |
Applicant |
ALTUS MEDICAL, INC. |
821 COWAN RD. |
BURLINGAME,
CA
94010
|
|
Applicant Contact |
KATHY MAYNOR |
Correspondent |
ALTUS MEDICAL, INC. |
821 COWAN RD. |
BURLINGAME,
CA
94010
|
|
Correspondent Contact |
KATHY MAYNOR |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 07/10/2002 |
Decision Date | 10/08/2002 |
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
|