VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED

Suture, Nonabsorbable, Synthetic, Polyamide

UNILENE S.A.C.

The following data is part of a premarket notification filed by Unilene S.a.c. with the FDA for Vital Sutures Suturex Cirugia Peruana Sutumed.

Pre-market Notification Details

• Device ID: K123034
• 510k Number: K123034
• Device Name: VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED
• Classification: Suture, Nonabsorbable, Synthetic, Polyamide
• Applicant: UNILENE S.A.C. 33 Golden Eagle Lane Littleton, CO 80127
• Contact: Kevin Walls
• Correspondent: Kevin Walls; UNILENE S.A.C. 33 Golden Eagle Lane Littleton, CO 80127
• Product Code: GAR
• Subsequent Product Code: GAP
• Subsequent Product Code: GAW
• CFR Regulation Number: 878.5020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-09-28
• Decision Date: 2013-05-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07757093049166	K123034	000
07757093059677	K123034	000
07757093059752	K123034	000
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