SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC

• K Number: K043526
• Device Name: SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC
• Manufacturer: NOBLE FIBER TECHNOLOGIES, INC.
• Date Cleared: 2005-03-10 ( 79 days)
• Product Code: LGF
• Regulation Number: 888.5940

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 888.5940 Cast component.

(a)
Identification. A cast component is a device intended for medical purposes to protect or support a cast. This generic type of device includes the cast heel, toe cap, cast support, and walking iron.(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 § 888.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records, and § 820.198, regarding complaint files.

Summary

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