Device Classification Name |
Unit, Cryosurgical, Accessories
|
510(k) Number |
K955011 |
Device Name |
CANDELA HCS 2000 URETHERAL WARMER CATHETER |
Applicant |
CANDELA LASER CORP. |
555 THIRTEENTH STREET, N.W |
WASHINGTON,
DC
20004 -1109
|
|
Applicant Contact |
JONATHAN S KAHAN |
Correspondent |
CANDELA LASER CORP. |
555 THIRTEENTH STREET, N.W |
WASHINGTON,
DC
20004 -1109
|
|
Correspondent Contact |
JONATHAN S KAHAN |
Regulation Number | 878.4350
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/01/1995 |
Decision Date | 04/03/1996 |
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
|