Device Classification Name |
unit, cryosurgical, accessories
|
510(k) Number |
K880416 |
Device Name |
WCCS 800 WALLACH CARDIAC CRYOSURGICAL SYSTEM |
Applicant |
WALLACH SURGICAL DEVICES, INC. |
291 PEPE'S FARM RD. |
MILFORD,
CT
06460
|
|
Applicant Contact |
VINCENT FRAZZETTA |
Correspondent |
WALLACH SURGICAL DEVICES, INC. |
291 PEPE'S FARM RD. |
MILFORD,
CT
06460
|
|
Correspondent Contact |
VINCENT FRAZZETTA |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 02/01/1988 |
Decision Date | 09/26/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|