ESI — Polymer, Natural-Absorbable Gelatin Material Class III

FDA Device Classification

FDA product code ESI covers "Polymer, Natural-Absorbable Gelatin Material", a Class III medical device. Submissions are reviewed by the Unknown panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
ESI
Device Class
Class III
Regulation Number
Submission Type
Review Panel
EN
Medical Specialty
Unknown
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K954401patrick c. jacobssenGASTROTECApril 25, 1996
K911212leisegang medicalLM-150HT LIGHT SOURCEMay 23, 1991