PROXIDERM (D-460,D 90 460,D 180,460, PS 460)

• K Number: K970439
• Device Name: PROXIDERM (D-460,D 90 460,D 180,460, PS 460)
• Manufacturer: PROGRESSIVE SURGICAL PRODUCTS, INC.
• Date Cleared: 1997-04-16 ( 70 days)
• Product Code: MKY
• Regulation Number: 878.4320
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 878.4320 Removable skin clip.

(a)
Identification. A removable skin clip is a clip-like device intended to connect skin tissues temporarily to aid healing. It is not absorbable.(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 § 878.9.