Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K984310 |
Device Name |
MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE |
Applicant |
MOSS TUBES, INC. |
304 VERONA AVE. |
ELIZABETH,
NJ
07208
|
|
Applicant Contact |
HARRY A SCHLAKMAN |
Correspondent |
MOSS TUBES, INC. |
304 VERONA AVE. |
ELIZABETH,
NJ
07208
|
|
Correspondent Contact |
HARRY A SCHLAKMAN |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 12/02/1998 |
Decision Date | 02/24/1999 |
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
|
|
|