Device Classification Name |
accessories, cleaning, for endoscope
|
510(k) Number |
K914145 |
FOIA Releasable 510(k) |
K914145
|
Device Name |
DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES |
Applicant |
MEDIVATORS, INC. |
C/O C. G. BUNDY ASSOCIATES |
6470 RIVERVIEW TERRACE |
MINNEAPOLIS,
MN
55432
|
|
Applicant Contact |
CONSTANCE G BUNDY |
Correspondent |
MEDIVATORS, INC. |
C/O C. G. BUNDY ASSOCIATES |
6470 RIVERVIEW TERRACE |
MINNEAPOLIS,
MN
55432
|
|
Correspondent Contact |
CONSTANCE G BUNDY |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/16/1991 |
Decision Date | 02/22/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|