Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K070705 |
Device Name |
MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039 |
Applicant |
VYGON CORP. |
2495 GENERAL ARMISTEAD AVE |
NORRISTOWN,
PA
19403
|
|
Applicant Contact |
COURTNEY SMITH |
Correspondent |
VYGON CORP. |
2495 GENERAL ARMISTEAD AVE |
NORRISTOWN,
PA
19403
|
|
Correspondent Contact |
Jay F W |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 03/14/2007 |
Decision Date | 11/30/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|