The following data is part of a premarket notification filed by Patrick C. Jacobssen with the FDA for Gastrotec.
| Device ID | K954401 |
| 510k Number | K954401 |
| Device Name: | GASTROTEC |
| Classification | Polymer, Natural-absorbable Gelatin Material |
| Applicant | PATRICK C. JACOBSSEN 19730 HUNTRS LOOP FAIRHOPE, AL 36532 |
| Contact | PATRICK C JACOBSSEN |
| Correspondent | PATRICK C JACOBSSEN PATRICK C. JACOBSSEN 19730 HUNTRS LOOP FAIRHOPE, AL 36532 |
| Product Code | ESI |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-20 |
| Decision Date | 1996-04-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GASTROTEC 73501267 not registered Dead/Abandoned |
GASTROTEC A.G. 1984-09-25 |