Device Classification Name |
cystoscope and accessories, flexible/rigid
|
510(k) Number |
K031141 |
Device Name |
ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE |
Applicant |
ASAP ENDOSCOPIC PRODUCTS GMBH |
KATHARINENSTR. 5 |
LUEBECK,
DE
23554
|
|
Applicant Contact |
MARTINA GUNDEROTH |
Correspondent |
ASAP ENDOSCOPIC PRODUCTS GMBH |
KATHARINENSTR. 5 |
LUEBECK,
DE
23554
|
|
Correspondent Contact |
MARTINA GUNDEROTH |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 04/10/2003 |
Decision Date | 06/30/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|