MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)

Splint, Intranasal Septal

ENTRIGUE SURGICAL, INC.

The following data is part of a premarket notification filed by Entrigue Surgical, Inc. with the FDA for Medient Middle Turbinate Implant; (single Pack-1 Pair, Four Pack-4 Pair).

Pre-market Notification Details

• Device ID: K130354
• 510k Number: K130354
• Device Name: MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)
• Classification: Splint, Intranasal Septal
• Applicant: ENTRIGUE SURGICAL, INC. 12672 SILICON DR. STE 150 San Antonio, TX 78249
• Contact: Gabriele G Niederauer
• Correspondent: Gabriele G Niederauer; ENTRIGUE SURGICAL, INC. 12672 SILICON DR. STE 150 San Antonio, TX 78249
• Product Code: LYA
• CFR Regulation Number: 874.4780 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-02-12
• Decision Date: 2013-05-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20817470009761	K130354	000
00817470009750	K130354	000