Device Classification Name |
warmer, thermal, infusion fluid
|
510(k) Number |
K072080 |
Device Name |
NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600, |
Applicant |
SMITHS MEDICAL ASD, INC. |
160 WEYMOUTH ST. |
ROCKLAND,
MA
02370
|
|
Applicant Contact |
CYNTHIA ENGELHARDT |
Correspondent |
SMITHS MEDICAL ASD, INC. |
160 WEYMOUTH ST. |
ROCKLAND,
MA
02370
|
|
Correspondent Contact |
CYNTHIA ENGELHARDT |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 07/30/2007 |
Decision Date | 06/02/2008 |
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
|
|
|