The following data is part of a premarket notification filed by Theo Manufacturing Bv with the FDA for L-mesitran Hydro, L-mesitran Border, L-mesitran Net, L-mesitran Active.
| Device ID | K053613 |
| 510k Number | K053613 |
| Device Name: | L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE |
| Classification | Dressing, Wound, Drug |
| Applicant | THEO MANUFACTURING BV 1467 VIGILANTE AVE. Bailey, CO 80421 |
| Contact | Barbara Debiase |
| Correspondent | Barbara Debiase THEO MANUFACTURING BV 1467 VIGILANTE AVE. Bailey, CO 80421 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-12-27 |
| Decision Date | 2007-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717249680857 | K053613 | 000 |
| 08717249680840 | K053613 | 000 |
| 87172496807278 | K053613 | 000 |