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.
|Device Name:||Non Absorbable Surgical Nylon Suture|
|Classification||Suture, Nonabsorbable, Synthetic, Polyamide|
|Applicant||Shandong Haidike Medical Product Co., Ltd. Tianfu Road, Dongcheng District, Shan County Heze, CN 274300|
Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120
|CFR Regulation Number||878.5020 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|