Device Classification Name |
susceptibility test discs, antimicrobial
|
510(k) Number |
K020842 |
Device Name |
ERTAPENEM 10UG BBL SENSI-DISC |
Applicant |
BECTON DICKINSON & CO. |
7 LOVETON CIR. |
SPARKS,
MD
21152 -0999
|
|
Applicant Contact |
MICHELLE BANDY |
Correspondent |
BECTON DICKINSON & CO. |
7 LOVETON CIR. |
SPARKS,
MD
21152 -0999
|
|
Correspondent Contact |
MICHELLE BANDY |
Regulation Number | 866.1620
|
Classification Product Code |
|
Date Received | 03/15/2002 |
Decision Date | 05/15/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|