510(k) K954401
K954401 is an FDA 510(k) premarket notification submitted by Patrick C. Jacobssen for the device "GASTROTEC". The FDA issued a decision of Substantially Equivalent on April 25, 1996. The device falls under product code ESI (Polymer, Natural-Absorbable Gelatin Material), a Class III device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 1996
- Date Received
- September 20, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Polymer, Natural-Absorbable Gelatin Material
- Device Class
- Class III
- Regulation Number
- Review Panel
- EN
- Submission Type