Device Classification Name |
stretcher, wheeled
|
510(k) Number |
K113598 |
Device Name |
POWER-LOAD COT FASTENER SYSTEM |
Applicant |
STRYKER MEDICAL |
3800 E. CENTRE AVE. |
PORTAGE,
MI
49002
|
|
Applicant Contact |
RENATA SILA |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
BHAVESH V SHETH |
Regulation Number | 880.6910
|
Classification Product Code |
|
Date Received | 12/05/2011 |
Decision Date | 12/20/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|