Device Classification Name |
Endoscopic Injection Needle, Gastroenterology-Urology
|
510(k) Number |
K955558 |
Device Name |
GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES |
Applicant |
MEDI-GLOBE CORP. |
6202 SOUTH MAPLE AVE. # 131 |
TEMPE,
AZ
85283
|
|
Applicant Contact |
GINA M GALLEGOS |
Correspondent |
MEDI-GLOBE CORP. |
6202 SOUTH MAPLE AVE. # 131 |
TEMPE,
AZ
85283
|
|
Correspondent Contact |
GINA M GALLEGOS |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 12/06/1995 |
Decision Date | 02/29/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|