The following data is part of a premarket notification filed by Theo Manufacturing Bv with the FDA for L-mesitran Dressing Family Ii- Soft And Tulle.
| Device ID | K150676 |
| 510k Number | K150676 |
| Device Name: | L-Mesitran Dressing Family II- Soft And Tulle |
| Classification | Dressing, Wound, Drug |
| Applicant | Theo Manufacturing BV Capucijnenstraat 71 Maastricht, NL 6211 Rp |
| Contact | Monique Gottgens |
| Correspondent | Monique Gottgens Theo Manufacturing BV Capucijnenstraat 71 Maastricht, NL 6211 Rp |
| 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 | 2015-03-16 |
| Decision Date | 2015-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784307831 | K150676 | 000 |
| 08717249680741 | K150676 | 000 |
| 08717249680734 | K150676 | 000 |
| 08717249680833 | K150676 | 000 |