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Device Classification
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ESF — Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent
Class II
FDA Device Classification
Classification Details
Product Code
ESF
Device Class
Class II
Regulation Number
878.3500
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
Yes
Recent 510(k) Clearances
K-Number
Applicant
Device Name
Date
K891247
siemens hearing instruments
BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC
March 29, 1989
K813224
xomed
CERAVITAL CERAMIC EAR CANAL WALL PROSTH
April 21, 1982