FDA 510(k) Applications Submitted by SHERRIE COVAL-GOLDSMITH
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K020031 |
01/04/2002 |
EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302 |
NEOTHERMIA CORP. |
| K970099 |
01/13/1997 |
SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM |
NITINOL MEDICAL TECHNOLOGIES, INC. |
| K160273 |
02/02/2016 |
truFreeze System |
CSA MEDIAL, INC. |
| K150920 |
04/06/2015 |
truFreeze System |
CSA MEDICAL, INC. |
| K021577 |
05/14/2002 |
MODIFICATION TO EN-BLOC BIOPSY SYSTEM |
NEOTHERMIA CORP. |
| K041347 |
05/20/2004 |
MODIFICATION TO EN-BLOC BIOPSY SYSTEM |
NEOTHERMIA CORP. |
| K171522 |
05/25/2017 |
truFreeze Rapid AV Spray Kit |
CSA Medical, Inc. |
| K171626 |
06/02/2017 |
truFreeze System |
CSA Medical, Inc. |
| K161557 |
06/06/2016 |
truFreeze System |
CSA MEDICAL, INC. |
| K172041 |
07/06/2017 |
truFreeze System |
CSA Medical, Inc. |
| K963014 |
08/02/1996 |
SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM |
NITINOL MEDICAL TECHNOLOGIES, INC. |
| K963016 |
08/02/1996 |
SIMON NITINOL FILTER SYSTEM |
NITINOL MEDICAL TECHNOLOGIES, INC. |
| K042170 |
08/11/2004 |
EN-BLOC BIOPSY SYSTEM MODEL#777-110,777-001,777-002,777-006,777-301,777-302,777-115,777-120 |
NEOTHERMIA CORPORATION |
| K152668 |
09/17/2015 |
truFreeze System |
CSA MEDICAL, INC. |
| K162695 |
09/27/2016 |
truFreeze System |
CSA MEDICAL, INC. |
| K023413 |
10/11/2002 |
MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM |
NEOTHERMIA CORP. |
| K033427 |
10/28/2003 |
MODIFICATION TO EN-BLOC BIOPSY SYSTEM |
NEOTHERMIA CORP. |
| K163244 |
11/18/2016 |
truFreeze System |
CSA MEDICAL, INC. |
| K143625 |
12/22/2014 |
truFreeze System |
CSA MEDICAL, INC. |
|
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