IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING

• K Number: K964846
• Device Name: IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING
• Manufacturer: IMPLANTECH ASSOCIATES, INC.
• Date Cleared: 1997-02-12 ( 71 days)
• Product Code: MDA
• Regulation Number: 878.4025
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

Get notified when PDF is available

Device Description

Get notified when PDF is available

AI/ML Overview

Get notified when PDF is available

Regulation Number and Section

§ 878.4025 Silicone sheeting.

(a)
Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.(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.