Device Classification Name |
System, Thermal Regulating
|
510(k) Number |
K033021 |
FOIA Releasable 510(k) |
K033021
|
Device Name |
KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS |
Applicant |
KIMBERLY-CLARK CORP. |
1400 HOLCOMB BRIDGE RD. |
ROSWELL,
GA
30076
|
|
Applicant Contact |
RICHARD V WOLFE |
Correspondent |
KIMBERLY-CLARK CORP. |
1400 HOLCOMB BRIDGE RD. |
ROSWELL,
GA
30076
|
|
Correspondent Contact |
RICHARD V WOLFE |
Regulation Number | 870.5900
|
Classification Product Code |
|
Date Received | 09/26/2003 |
Decision Date | 11/12/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|