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System, Skin Closure

Page Type
Product Code
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
878.4320
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4320 Removable skin clip

§ 878.4320 Removable skin clip.

(a) Identification. A removable skin clip is a clip-like device intended to connect skin tissues temporarily to aid healing. It is not absorbable.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

[53 FR 23872, June 24, 1988, as amended at 65 FR 2318, Jan. 14, 2000]

System, Skin Closure

Page Type
Product Code
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
878.4320
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4320 Removable skin clip

§ 878.4320 Removable skin clip.

(a) Identification. A removable skin clip is a clip-like device intended to connect skin tissues temporarily to aid healing. It is not absorbable.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

[53 FR 23872, June 24, 1988, as amended at 65 FR 2318, Jan. 14, 2000]