Device Classification Name |
endoscope, mirror
|
510(k) Number |
K862717 |
Device Name |
HAND MIRROR (ENDOSCOPE) |
Applicant |
SIMPSON/BASYE, INC. |
430 AYRE ST. |
WILMINGTON,
DE
19804
|
|
Applicant Contact |
ROBERT BASYE |
Correspondent |
SIMPSON/BASYE, INC. |
430 AYRE ST. |
WILMINGTON,
DE
19804
|
|
Correspondent Contact |
ROBERT BASYE |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/17/1986 |
Decision Date | 07/30/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|