Last synced on 2 December 2022 at 11:04 pm

Implant, Malar

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
878.3550
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.3550 Chin prosthesis

§ 878.3550 Chin prosthesis.

(a) Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.

(b) Classification. Class II.

Implant, Malar

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
878.3550
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.3550 Chin prosthesis

§ 878.3550 Chin prosthesis.

(a) Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.

(b) Classification. Class II.