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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name appliance, fixation, spinal intervertebral body
510(k) Number K191786
Device Name Cyclops™ Anterior Cervical Plate System
Applicant
DeGen Medical INC
1321-C North Cashua Drive
Florence,  SC  29501
Applicant Contact Craig Black
Correspondent
Secure BioMed Evaluations
7828 Hickory Flat Highway Suite 120
Woodstock,  GA  30188
Correspondent Contact Linda Braddon
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received07/03/2019
Decision Date 08/30/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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