Device Classification Name |
Endoscopic Injection Needle, Gastroenterology-Urology
|
510(k) Number |
K000646 |
Device Name |
DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE |
Applicant |
ENTERIC MEDICAL TECHNOLOGIES |
1125 EAST HILLSDALE BLVD. |
SUITE 106 |
FOSTER CITY,
CA
94404
|
|
Applicant Contact |
JILL M VISOR |
Correspondent |
ENTERIC MEDICAL TECHNOLOGIES |
1125 EAST HILLSDALE BLVD. |
SUITE 106 |
FOSTER CITY,
CA
94404
|
|
Correspondent Contact |
JILL M VISOR |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 02/25/2000 |
Decision Date | 04/13/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|