Device Classification Name |
Media, Coupling, Ultrasound
|
510(k) Number |
K021132 |
Device Name |
UNI-PATCH ULTRASOUND COUPLING GEL |
Applicant |
THE LUDLOW COMPANY LP |
TWO LUDLOW PARK DR. |
CHICOPEE,
MA
01022
|
|
Applicant Contact |
M. BETH RICE |
Correspondent |
THE LUDLOW COMPANY LP |
TWO LUDLOW PARK DR. |
CHICOPEE,
MA
01022
|
|
Correspondent Contact |
M. BETH RICE |
Regulation Number | 892.1570
|
Classification Product Code |
|
Date Received | 04/09/2002 |
Decision Date | 05/15/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|