WEGO-PGCL Absorbable Surgical Monofilament Suture

Suture, Absorbable, Synthetic, Polyglycolic Acid

FOOSIN MEDICAL SUPPLIES INC.LTD

The following data is part of a premarket notification filed by Foosin Medical Supplies Inc.ltd with the FDA for Wego-pgcl Absorbable Surgical Monofilament Suture.

Pre-market Notification Details

• Device ID: K142810
• 510k Number: K142810
• Device Name: WEGO-PGCL Absorbable Surgical Monofilament Suture
• Classification: Suture, Absorbable, Synthetic, Polyglycolic Acid
• Applicant: FOOSIN MEDICAL SUPPLIES INC.LTD No.20, Xingshan Road Weihai Torch Hi-tech Science Park Weihai, CN 264210
• Contact: Suxia Zhao
• Correspondent: Diana Hong; MID-LINK CONSULTING CO., LTD P.O. BOX 120-119 Shanghai, CN 200120
• Product Code: GAM
• CFR Regulation Number: 878.4493 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-09-29
• Decision Date: 2014-11-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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