The following data is part of a premarket notification filed by Tracoe Medical Gmbh with the FDA for Tracheostomy Tubes Tracoe-flex.
| Device ID | K961449 |
| 510k Number | K961449 |
| Device Name: | TRACHEOSTOMY TUBES TRACOE-FLEX |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | TRACOE MEDICAL GMBH REICHSFORSTSTR. 32 Frankfurt/m, DE D-60528 |
| Contact | Franz Waldeck, M.d., Ph.d. |
| Correspondent | Franz Waldeck, M.d., Ph.d. TRACOE MEDICAL GMBH REICHSFORSTSTR. 32 Frankfurt/m, DE D-60528 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-16 |
| Decision Date | 1996-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04035324028009 | K961449 | 000 |
| 04035324027996 | K961449 | 000 |
| 04035324027989 | K961449 | 000 |
| 04035324027972 | K961449 | 000 |
| 04035324027965 | K961449 | 000 |
| 04035324027958 | K961449 | 000 |
| 04035324027866 | K961449 | 000 |
| 04035324057016 | K961449 | 000 |