PROCEM

Cement, Ear, Nose And Throat

OTOTRONIX, LLC

The following data is part of a premarket notification filed by Ototronix, Llc with the FDA for Procem.

Pre-market Notification Details

Device IDK140644
510k NumberK140644
Device Name:PROCEM
ClassificationCement, Ear, Nose And Throat
Applicant OTOTRONIX, LLC 4486 TIMBERLINE CT St Paul,  MN  55127
ContactBernard Horwath
CorrespondentBernard Horwath
OTOTRONIX, LLC 4486 TIMBERLINE CT St Paul,  MN  55127
Product CodeNEA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-13
Decision Date2014-06-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M737P97401 K140644 000
M737P97301 K140644 000
M737P97201 K140644 000
M7379860041 K140644 000
M7379860031 K140644 000
M7379860021 K140644 000
M7379860011 K140644 000

Trademark Results [PROCEM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROCEM
PROCEM
75594644 2396966 Dead/Cancelled
CENTRE STEPHANOIS DE RECHERCHES MECANIQUES HYDROMECANIQUE ET FROTTEMENT
1998-11-24
PROCEM
PROCEM
75356361 2601343 Live/Registered
HOLCIM (US) INC.
1997-08-27
PROCEM
PROCEM
75075084 2088858 Dead/Cancelled
THERA Patent GmbH & Co. KG Gesellschaftfur Industrielle Schurtzrechte
1996-03-19

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