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 |