Device Classification Name |
wheelchair, mechanical
|
510(k) Number |
K974820 |
Device Name |
BREEZY SERIES |
Applicant |
SUNRISE MEDICAL, INC. |
7477 EAST DRY CREEK PKWY. |
LONGMONT,
CO
80503
|
|
Applicant Contact |
REBECCA ANDERSEN |
Correspondent |
SUNRISE MEDICAL, INC. |
7477 EAST DRY CREEK PKWY. |
LONGMONT,
CO
80503
|
|
Correspondent Contact |
REBECCA ANDERSEN |
Regulation Number | 890.3850
|
Classification Product Code |
|
Date Received | 12/23/1997 |
Decision Date | 01/27/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|