Device Classification Name |
Collector, Ostomy
|
510(k) Number |
K864189 |
Device Name |
ULTRA-GEL - #4083 |
Applicant |
JOHN F. GREER CO., INC. |
530 E. 12TH ST. |
OAKLAND,
CA
94606
|
|
Applicant Contact |
LELAND H GREER |
Correspondent |
JOHN F. GREER CO., INC. |
530 E. 12TH ST. |
OAKLAND,
CA
94606
|
|
Correspondent Contact |
LELAND H GREER |
Regulation Number | 876.5900
|
Classification Product Code |
|
Date Received | 10/27/1986 |
Decision Date | 12/04/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|