Device Classification Name |
Dynamometer, Ac-Powered
|
510(k) Number |
K052309 |
FOIA Releasable 510(k) |
K052309
|
Device Name |
DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006 |
Applicant |
SAEHAN CORP. |
340 SHADY GROVE ROAD |
FLINTVILLE,
TN
37335
|
|
Applicant Contact |
CHARLIE MACK |
Correspondent |
SAEHAN CORP. |
340 SHADY GROVE ROAD |
FLINTVILLE,
TN
37335
|
|
Correspondent Contact |
CHARLIE MACK |
Regulation Number | 888.1240
|
Classification Product Code |
|
Date Received | 08/24/2005 |
Decision Date | 09/27/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|