MANI NEEDLE & SUTURE PACK (NYLON)

Suture, Nonabsorbable, Synthetic, Polyamide

MANI, INC.

The following data is part of a premarket notification filed by Mani, Inc. with the FDA for Mani Needle & Suture Pack (nylon).

Pre-market Notification Details

• Device ID: K053637
• 510k Number: K053637
• Device Name: MANI NEEDLE & SUTURE PACK (NYLON)
• Classification: Suture, Nonabsorbable, Synthetic, Polyamide
• Applicant: MANI, INC. 1301K STREET, N.W. SUITE 1100 - EAST TOWER Washington, DC 20005 -3373
• Contact: David J Bloch
• Correspondent: David J Bloch; MANI, INC. 1301K STREET, N.W. SUITE 1100 - EAST TOWER Washington, DC 20005 -3373
• Product Code: GAR
• CFR Regulation Number: 878.5020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-12-29
• Decision Date: 2006-05-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
14546951401761	K053637	000
14546951401327	K053637	000
14546951401310	K053637	000
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