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Handpiece (Brace), Drill

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
882.4325
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.4325 Cranial drill handpiece (brace)

§ 882.4325 Cranial drill handpiece (brace).

(a) Identification. A cranial drill handpiece (brace) is a hand holder, which is used without a power source, for drills, burrs, trephines, or other cutting tools that are used on a patient's skull.

(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 § 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38808, July 25, 2001]

Handpiece (Brace), Drill

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
882.4325
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.4325 Cranial drill handpiece (brace)

§ 882.4325 Cranial drill handpiece (brace).

(a) Identification. A cranial drill handpiece (brace) is a hand holder, which is used without a power source, for drills, burrs, trephines, or other cutting tools that are used on a patient's skull.

(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 § 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38808, July 25, 2001]