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510(k) K231183

Device
Non absorbable Surgical Polyester Suture
Applicant
Shandong Haidike Medical Products Co., Ltd.
510(k) number
K231183
Product code
GAT
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-25
Date received
2023-04-26
Regulation
878.5000
Classification name
Suture, Nonabsorbable, Synthetic, Polyethylene
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

Other 510(k) Records For Product Code GAT#

510(k), Device, Applicant table
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K242201HyperSuture White/Green Extension LineThreadstone, LLC2025-03-27
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K231163HS Fiber SuturesRiverpoint Medical2024-01-05
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K223500SuperBall Meniscal Repair SystemArcuro Medical , Ltd.2023-08-10
K223122MENIX®; MENIX® DUOS.B.M. Sas (Science & Bio Materials)2023-08-03
K230510MyEllevateCynosure, LLC2023-07-06