Monopolar Cord

FDA 510(k) Premarket Notification · Submission K193004 · Applicant: New Deantronics Taiwan , Ltd.

Public Record 510(k) Submission Decision Date: 2019-12-19 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K193004.

Source Dataset
FDA 510(k) Premarket Notifications
510(k) Number
K193004
Applicant / Sponsor
Device Name
Monopolar Cord
Product Code
GEI
Decision Date
2019-12-19
Decision / Status
Substantially Equivalent (SESE)
Advisory Committee
General, Plastic Surgery (SU)
Clearance Type
Traditional
Third Party Flag
N
Date Received
2019-10-28

Related Establishments / Registrations

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