Device Classification Name |
Pump, Portable, Aspiration (Manual Or Powered)
|
510(k) Number |
K052626 |
Device Name |
SMARTSUCTION HARMONY DEVICE |
Applicant |
HAEMONETICS CORP. |
400 WOOD ROAD |
BRAINTREE,
MA
02184 -9114
|
|
Applicant Contact |
GABRIEL J MURACA |
Correspondent |
TUV RHEINLAND OF NORTH AMERICA, INC. |
12 COMMERCE RD. |
NEWTON,
CT
06470
|
|
Correspondent Contact |
TAMAS BORSAI |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 09/23/2005 |
Decision Date | 10/05/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|