Device Classification Name |
lamp, endoscope, incandescent
|
510(k) Number |
K914397 |
Device Name |
OXFORD OPTRONIX MPM 3S |
Applicant |
DIA-STRON, LTD. |
835-837 SUSSEX BLVD. |
BROOMALL,
PA
19008 -4310
|
|
Applicant Contact |
MR. S RIMDZIUS |
Correspondent |
DIA-STRON, LTD. |
835-837 SUSSEX BLVD. |
BROOMALL,
PA
19008 -4310
|
|
Correspondent Contact |
MR. S RIMDZIUS |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/01/1991 |
Decision Date | 11/16/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|