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Microscope, Surgical

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
878.4700
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4700 Surgical microscope and accessories

§ 878.4700 Surgical microscope and accessories.

(a) Identification. A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.

(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 § 878.9.

[55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001]

Microscope, Surgical

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
878.4700
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4700 Surgical microscope and accessories

§ 878.4700 Surgical microscope and accessories.

(a) Identification. A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.

(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 § 878.9.

[55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001]