Device Classification Name |
Polymer, Natural-Absorbable Gelatin Material
|
510(k) Number |
K954401 |
Device Name |
GASTROTEC |
Applicant |
PATRICK C. JACOBSSEN |
19730 HUNTRS LOOP |
FAIRHOPE,
AL
36532
|
|
Applicant Contact |
PATRICK C JACOBSSEN |
Correspondent |
PATRICK C. JACOBSSEN |
19730 HUNTRS LOOP |
FAIRHOPE,
AL
36532
|
|
Correspondent Contact |
PATRICK C JACOBSSEN |
Classification Product Code |
|
Date Received | 09/20/1995 |
Decision Date | 04/25/1996 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|