Device Classification Name |
needle, conduction, anesthetic (w/wo introducer)
|
510(k) Number |
K951928 |
Device Name |
DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE) |
Applicant |
CSEN LTD. |
P.O. BOX 27476 |
JERUSALEM 91273 |
ISRAEL,
IL
|
|
Applicant Contact |
JOSEPH ELDOR |
Correspondent |
CSEN LTD. |
P.O. BOX 27476 |
JERUSALEM 91273 |
ISRAEL,
IL
|
|
Correspondent Contact |
JOSEPH ELDOR |
Regulation Number | 868.5150
|
Classification Product Code |
|
Date Received | 04/25/1995 |
Decision Date | 05/30/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|