MONTERIS MEDICAL NEUROBLATE SYSTEM

FDA 510(k) Premarket Notification · Submission K131278 · Applicant: Monteris Medical, Inc.

Public Record 510(k) Submission Decision Date: 2013-07-11 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K131278.

Source Dataset
FDA 510(k) Premarket Notifications
510(k) Number
K131278
Applicant / Sponsor
Device Name
MONTERIS MEDICAL NEUROBLATE SYSTEM
Product Code
GEX
Decision Date
2013-07-11
Decision / Status
Substantially Equivalent (SESE)
Advisory Committee
General, Plastic Surgery (SU)
Clearance Type
Traditional
Third Party Flag
N
Date Received
2013-05-06

Related Establishments / Registrations

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