Device Classification Name |
non-bronchoscopic bronchoalveolar lavage catheter
|
510(k) Number |
K112562 |
Device Name |
BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER |
Applicant |
KIMBERLY-CLARK |
1400 HOLCOMB BRIDGE ROAD |
ROSWELL,
GA
30076
|
|
Applicant Contact |
DAVID LEE |
Correspondent |
KIMBERLY-CLARK |
1400 HOLCOMB BRIDGE ROAD |
ROSWELL,
GA
30076
|
|
Correspondent Contact |
DAVID LEE |
Regulation Number | 868.6810
|
Classification Product Code |
|
Date Received | 09/26/2011 |
Decision Date | 12/15/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|