The following data is part of a premarket notification filed by Bauerfeind Ag with the FDA for Venotrain Curaflow.
| Device ID | K111662 |
| 510k Number | K111662 |
| Device Name: | VENOTRAIN CURAFLOW |
| Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
| Applicant | BAUERFEIND AG TRIEBESER STRASSE 16 Zeulenroda-triebes, DE 07937 |
| Contact | Ines Exner |
| Correspondent | Ines Exner BAUERFEIND AG TRIEBESER STRASSE 16 Zeulenroda-triebes, DE 07937 |
| Product Code | DWL |
| CFR Regulation Number | 880.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-14 |
| Decision Date | 2011-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04046445905803 | K111662 | 000 |
| 04046445905797 | K111662 | 000 |
| 04046445905780 | K111662 | 000 |