Device Classification Name |
Needle, Conduction, Anesthetic (W/Wo Introducer)
|
510(k) Number |
K943649 |
Device Name |
GERTIE MARX NEEDLE |
Applicant |
MANAN MEDICAL PRODUCTS, INC. |
2200 CARLSON DR. |
NORTHBROOK,
IL
60062
|
|
Applicant Contact |
FRED MITERMEIER |
Correspondent |
MANAN MEDICAL PRODUCTS, INC. |
2200 CARLSON DR. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
FRED MITERMEIER |
Regulation Number | 868.5150
|
Classification Product Code |
|
Date Received | 07/28/1994 |
Decision Date | 03/22/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|