Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K003190 |
Device Name |
EN BLOC BIOPSY SYSTEM |
Applicant |
NEOTHERMIA CORP. |
ONE APPLE HILL |
SUITE 316 |
NATICK,
MA
01760
|
|
Applicant Contact |
SHERRIE COVAL-GOLDMSITH |
Correspondent |
NEOTHERMIA CORP. |
ONE APPLE HILL |
SUITE 316 |
NATICK,
MA
01760
|
|
Correspondent Contact |
SHERRIE COVAL-GOLDMSITH |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/11/2000 |
Decision Date | 06/11/2001 |
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
|
Recalls |
CDRH Recalls
|