DESARA SL

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

CALDERA MEDICAL, INC.

The following data is part of a premarket notification filed by Caldera Medical, Inc. with the FDA for Desara Sl.

Pre-market Notification Details

• Device ID: K121928
• 510k Number: K121928
• Device Name: DESARA SL
• Classification: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
• Applicant: CALDERA MEDICAL, INC. 5171 CLARETON DRIVE Agoura Hills, CA 91301
• Contact: Vicki Gail
• Correspondent: Vicki Gail; CALDERA MEDICAL, INC. 5171 CLARETON DRIVE Agoura Hills, CA 91301
• Product Code: OTN
• CFR Regulation Number: 878.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-07-02
• Decision Date: 2013-02-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00089059400766	K121928	000
00890594000766	K121928	000
00890594000070	K121928	000