The following data is part of a premarket notification filed by Unoplast A/s with the FDA for Nelaton-, Female - Or Tiemann Catheter.
| Device ID | K896729 |
| 510k Number | K896729 |
| Device Name: | NELATON-, FEMALE - OR TIEMANN CATHETER |
| Classification | Catheter, Urological |
| Applicant | UNOPLAST A/S DK-3390 HUNDESTED Denmark, DK |
| Contact | Erik Andersen |
| Correspondent | Erik Andersen UNOPLAST A/S DK-3390 HUNDESTED Denmark, DK |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-30 |
| Decision Date | 1990-11-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00768455145591 | K896729 | 000 |
| 00768455145492 | K896729 | 000 |
| 00768455145546 | K896729 | 000 |
| 00768455145553 | K896729 | 000 |
| 00768455145607 | K896729 | 000 |
| 00768455145485 | K896729 | 000 |
| 00768455145577 | K896729 | 000 |
| 00768455145447 | K896729 | 000 |
| 00768455145461 | K896729 | 000 |
| 00768455145478 | K896729 | 000 |
| 00768455145539 | K896729 | 000 |
| 00768455145560 | K896729 | 000 |
| 00768455145584 | K896729 | 000 |
| 00768455145454 | K896729 | 000 |