Device Classification Name |
needle, conduction, anesthetic (w/wo introducer)
|
510(k) Number |
K961444 |
Device Name |
GLOBAL MEDICAL COMBINED SPINAL EPIDURAL KIT (GMA 1827 AND GMA 1725) |
Applicant |
GLOBAL MEDICAL PRODUCTS, LTD. |
244 MAIN ST., SOUTH |
P.O. BOX 505 |
WOODBURY,
CT
06798 -0505
|
|
Applicant Contact |
PETER CLARK |
Correspondent |
GLOBAL MEDICAL PRODUCTS, LTD. |
244 MAIN ST., SOUTH |
P.O. BOX 505 |
WOODBURY,
CT
06798 -0505
|
|
Correspondent Contact |
PETER CLARK |
Regulation Number | 868.5150
|
Classification Product Code |
|
Date Received | 04/15/1996 |
Decision Date | 08/01/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|