Device Classification Name |
Instrument, Biopsy, Mechanical, Gastrointestinal
|
510(k) Number |
K915142 |
Device Name |
AMCATH DISPOSABLE BIOPSY FORCEPS |
Applicant |
INTL. MEDICAL, INC. |
175 CONNECTICUT MILLS AVE. |
DANIELSON,
CT
06239
|
|
Applicant Contact |
PETER WETTERMANN |
Correspondent |
INTL. MEDICAL, INC. |
175 CONNECTICUT MILLS AVE. |
DANIELSON,
CT
06239
|
|
Correspondent Contact |
PETER WETTERMANN |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 11/14/1991 |
Decision Date | 01/10/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|