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 |