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Applicator (Laryngo-Tracheal), Topical Anesthesia

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5170
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 868.5170 Laryngotracheal topical anesthesia applicator

§ 868.5170 Laryngotracheal topical anesthesia applicator.

(a) Identification. A laryngotracheal topical anesthesia applicator is a device used to apply topical anesthetics to a patient's laryngotracheal area.

(b) Classification. Class II (performance standards).

Applicator (Laryngo-Tracheal), Topical Anesthesia

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5170
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 868.5170 Laryngotracheal topical anesthesia applicator

§ 868.5170 Laryngotracheal topical anesthesia applicator.

(a) Identification. A laryngotracheal topical anesthesia applicator is a device used to apply topical anesthetics to a patient's laryngotracheal area.

(b) Classification. Class II (performance standards).