Device Classification Name |
unit, electrosurgical, endoscopic (with or without accessories)
|
510(k) Number |
K884252 |
Device Name |
CIRCON ACMI BICAP HEMORRHOID SYSTEM BH-10 & BHP-20 |
Applicant |
CIRCON ACMI |
300 STILLWATER AVE. |
P.O. BOX 1971 |
STAMFORD,
CT
06904 -1971
|
|
Applicant Contact |
TAYLOR, P.E. |
Correspondent |
CIRCON ACMI |
300 STILLWATER AVE. |
P.O. BOX 1971 |
STAMFORD,
CT
06904 -1971
|
|
Correspondent Contact |
TAYLOR, P.E. |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 10/11/1988 |
Decision Date | 01/10/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|