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Splint, Intranasal Septal, Cber Led

Page Type
Product Code
Definition
Splint, Intranasal Septal, CBER led
Physical State
Splint, Intranasal Septal, CBER led
Technical Method
Splint, Intranasal Septal, CBER led
Target Area
Splint, Intranasal Septal, CBER led
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Ear, Nose, Throat
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
874.4780
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 874.4780 Intranasal splint

§ 874.4780 Intranasal splint.

(a) Identification. An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.

(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 the limitations in § 874.9.

[64 FR 10949, Mar. 8, 1999]

Splint, Intranasal Septal, Cber Led

Page Type
Product Code
Definition
Splint, Intranasal Septal, CBER led
Physical State
Splint, Intranasal Septal, CBER led
Technical Method
Splint, Intranasal Septal, CBER led
Target Area
Splint, Intranasal Septal, CBER led
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Ear, Nose, Throat
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
874.4780
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 874.4780 Intranasal splint

§ 874.4780 Intranasal splint.

(a) Identification. An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.

(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 the limitations in § 874.9.

[64 FR 10949, Mar. 8, 1999]