Non Absorbable Surgical Nylon Suture

Suture, Nonabsorbable, Synthetic, Polyamide

Shandong Haidike Medical Product Co., Ltd.

The following data is part of a premarket notification filed by Shandong Haidike Medical Product Co., Ltd. with the FDA for Non Absorbable Surgical Nylon Suture.

Pre-market Notification Details

Device IDK212603
510k NumberK212603
Device Name:Non Absorbable Surgical Nylon Suture
ClassificationSuture, Nonabsorbable, Synthetic, Polyamide
Applicant Shandong Haidike Medical Product Co., Ltd. Tianfu Road, Dongcheng District, Shan County Heze,  CN 274300
ContactLili Xu
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai,  CN 200120
Product CodeGAR  
CFR Regulation Number878.5020 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-17
Decision Date2021-12-22

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