Device Classification Name |
Anesthesia Conduction Kit
|
510(k) Number |
K962821 |
Device Name |
EPIDURAL ANESTHESIA KIT AND COMBINED SPINAL EPIDURAL ANESTHESIA KIT |
Applicant |
GLOBAL MEDICAL PRODUCTS, LTD. |
244 MAIN ST., SOUTH |
P.O. BOX 505 |
WOODBURY,
CT
06798 -0505
|
|
Applicant Contact |
PETER M CLARK |
Correspondent |
GLOBAL MEDICAL PRODUCTS, LTD. |
244 MAIN ST., SOUTH |
P.O. BOX 505 |
WOODBURY,
CT
06798 -0505
|
|
Correspondent Contact |
PETER M CLARK |
Regulation Number | 868.5140
|
Classification Product Code |
|
Date Received | 07/19/1996 |
Decision Date | 11/13/1996 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|