Device Classification Name |
Wheelchair, Mechanical
|
510(k) Number |
K982607 |
Device Name |
MANUAL WHEELCHAIR |
Applicant |
G. HIRSCH AND CO., INC. |
1815 ROLLINS RD. |
BURLINGAME,
CA
94010
|
|
Applicant Contact |
GARY HIRSCH |
Correspondent |
G. HIRSCH AND CO., INC. |
1815 ROLLINS RD. |
BURLINGAME,
CA
94010
|
|
Correspondent Contact |
GARY HIRSCH |
Regulation Number | 890.3850 |
Classification Product Code |
|
Date Received | 07/27/1998 |
Decision Date | 08/31/1998 |
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
|
Predetermined Change Control Plan Authorized |
No
|
|
|