Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K861051 |
Device Name |
ISOLIFE DISPENSING SYSTEM |
Applicant |
NAVACO LABORATORIES |
412 ASH AVE. |
MCALLEN,
TX
78501
|
|
Applicant Contact |
SCHROCK, SR. |
Correspondent |
NAVACO LABORATORIES |
412 ASH AVE. |
MCALLEN,
TX
78501
|
|
Correspondent Contact |
SCHROCK, SR. |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 03/19/1986 |
Decision Date | 04/03/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|