Device Classification Name |
transducer, ultrasonic, diagnostic
|
510(k) Number |
K970514 |
Device Name |
DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE |
Applicant |
CIVCO MEDICAL INSTRUMENTS CO., INC. |
102 1ST ST. SOUTH |
KALONA,
IA
52247
|
|
Applicant Contact |
J. WILLIAM JONES |
Correspondent |
CIVCO MEDICAL INSTRUMENTS CO., INC. |
102 1ST ST. SOUTH |
KALONA,
IA
52247
|
|
Correspondent Contact |
J. WILLIAM JONES |
Regulation Number | 892.1570
|
Classification Product Code |
|
Date Received | 02/11/1997 |
Decision Date | 06/20/1997 |
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
|
|
|