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 ID | K140644 |
| 510k Number | K140644 |
| Device Name: | PROCEM |
| Classification | Cement, Ear, Nose And Throat |
| Applicant | OTOTRONIX, LLC 4486 TIMBERLINE CT St Paul, MN 55127 |
| Contact | Bernard Horwath |
| Correspondent | Bernard Horwath OTOTRONIX, LLC 4486 TIMBERLINE CT St Paul, MN 55127 |
| Product Code | NEA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-13 |
| Decision Date | 2014-06-19 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 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 75594644 2396966 Dead/Cancelled |
CENTRE STEPHANOIS DE RECHERCHES MECANIQUES HYDROMECANIQUE ET FROTTEMENT 1998-11-24 |
 PROCEM 75356361 2601343 Live/Registered |
HOLCIM (US) INC. 1997-08-27 |
 PROCEM 75075084 2088858 Dead/Cancelled |
THERA Patent GmbH & Co. KG Gesellschaftfur Industrielle Schurtzrechte 1996-03-19 |
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