Device Classification Name |
System, Imaging, Pulsed Echo, Ultrasonic
|
510(k) Number |
K961029 |
Device Name |
KILTEX PROBE COVER |
Applicant |
KILTEX CORP. |
2064 KILLIAN RD. |
AKRON,
OH
44312
|
|
Applicant Contact |
TIMOTHY J KILLIAN |
Correspondent |
KILTEX CORP. |
2064 KILLIAN RD. |
AKRON,
OH
44312
|
|
Correspondent Contact |
TIMOTHY J KILLIAN |
Regulation Number | 892.1560
|
Classification Product Code |
|
Date Received | 03/14/1996 |
Decision Date | 07/25/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|