Last synced on 29 September 2023 at 11:04 pm

Prosthesis, Ear, Internal

Page Type
Product Code
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.3590
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.3590 Ear prosthesis

§ 878.3590 Ear prosthesis.

(a) Identification. An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the external ear.

(b) Classification. Class II.

Prosthesis, Ear, Internal

Page Type
Product Code
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.3590
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.3590 Ear prosthesis

§ 878.3590 Ear prosthesis.

(a) Identification. An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the external ear.

(b) Classification. Class II.