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Instrument, Clip, Forming/Cutting, Reprocessed

Page Type
Product Code
Definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 1
Regulation Number
882.4190
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 882.4190 Clip forming/cutting instrument

§ 882.4190 Clip forming/cutting instrument.

(a) Identification. A clip forming/cutting instrument is a device used by the physician to make tissue clips from wire stock.

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

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994]

Instrument, Clip, Forming/Cutting, Reprocessed

Page Type
Product Code
Definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 1
Regulation Number
882.4190
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 882.4190 Clip forming/cutting instrument

§ 882.4190 Clip forming/cutting instrument.

(a) Identification. A clip forming/cutting instrument is a device used by the physician to make tissue clips from wire stock.

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

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994]