Device Classification Name |
anesthesia conduction kit
|
510(k) Number |
K945484 |
Device Name |
PIDURAL STEROID SYSTEM |
Applicant |
PROFESSIONAL MEDICAL DEVICE CONSULTANTS |
561 EAST FAIROAKS WAY |
SANDY,
UT
84070
|
|
Applicant Contact |
JOHN B ROWE |
Correspondent |
PROFESSIONAL MEDICAL DEVICE CONSULTANTS |
561 EAST FAIROAKS WAY |
SANDY,
UT
84070
|
|
Correspondent Contact |
JOHN B ROWE |
Regulation Number | 868.5140
|
Classification Product Code |
|
Date Received | 11/08/1994 |
Decision Date | 06/02/1995 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|