Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K031492 |
Device Name |
MOSSMED DUAL INTERMITTENT ASPIRATOR |
Applicant |
MOSS MEDICAL PRODUCTS |
4049 NY 150 |
WEST SAND LAKE,
NY
12196
|
|
Applicant Contact |
GERALD MOSS |
Correspondent |
MOSS MEDICAL PRODUCTS |
4049 NY 150 |
WEST SAND LAKE,
NY
12196
|
|
Correspondent Contact |
GERALD MOSS |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 05/12/2003 |
Decision Date | 02/05/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|