MANI NEEDLE & SUTURE PACK (SILK)

Suture, Nonabsorbable, Silk

MANI, INC.

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

Pre-market Notification Details

• Device ID: K053638
• 510k Number: K053638
• Device Name: MANI NEEDLE & SUTURE PACK (SILK)
• Classification: Suture, Nonabsorbable, Silk
• 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: GAP
• CFR Regulation Number: 878.5030 [🔎]
• 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
04546951400545	K053638	000
04546951401504	K053638	000
04546951401610	K053638	000
04546951401634	K053638	000
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04546951401900	K053638	000
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04546951401931	K053638	000
04546951401948	K053638	000
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04546951402037	K053638	000
04546951402044	K053638	000
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04546951402235	K053638	000
04546951402358	K053638	000
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04546951400637	K053638	000
04546951400644	K053638	000
04546951400675	K053638	000
04546951400682	K053638	000
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04546951400828	K053638	000
04546951400842	K053638	000
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04546951400934	K053638	000
04546951400941	K053638	000
04546951400958	K053638	000
04546951400996	K053638	000
04546951401405	K053638	000
04546951402488	K053638	000
04546951402532	K053638	000
04546951402570	K053638	000
04546951500115	K053638	000
04546951500122	K053638	000
04546951500146	K053638	000
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