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510(k) K230746

Device
Non absorbable Surgical Polypropylene Suture
Applicant
Shandong Haidike Medical Products Co., Ltd.
510(k) number
K230746
Product code
GAW
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-14
Date received
2023-03-17
Regulation
878.5010
Classification name
Suture, Nonabsorbable, Synthetic, Polypropylene
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Yan Wang
Address
Tianfu Rd., Dongcheng District, Shan County Heze CN 274300 274300

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K171005Silhouette FeatherliftSilhouette Lift, Inc.2017-05-03
K162617NobleStitch ELNobles Medical Technologies Ii, Inc.2017-04-06
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