Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K994300 |
Device Name |
NASOGASTRIC TUBE HOLDER, MODEL 160 |
Applicant |
DALE MEDICAL PRODUCTS, INC. |
7 CROSS ST. |
P.O. BOX 1556 |
PLAINVILLE,
MA
02762
|
|
Applicant Contact |
JOHN C BREZACK |
Correspondent |
DALE MEDICAL PRODUCTS, INC. |
7 CROSS ST. |
P.O. BOX 1556 |
PLAINVILLE,
MA
02762
|
|
Correspondent Contact |
JOHN C BREZACK |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 12/21/1999 |
Decision Date | 02/10/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|