The following data is part of a premarket notification filed by Nobelpharma Usa, Inc. with the FDA for Ba-cpas.
| Device ID | K945154 |
| 510k Number | K945154 |
| Device Name: | BA-CPAS |
| Classification | Prosthesis, Nose, Internal |
| Applicant | NOBELPHARMA USA, INC. 777 OAKMONT LN. SUITE 100 Westmont, IL 60559 |
| Contact | Mary Edwards |
| Correspondent | Mary Edwards NOBELPHARMA USA, INC. 777 OAKMONT LN. SUITE 100 Westmont, IL 60559 |
| Product Code | FZE |
| CFR Regulation Number | 878.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-21 |
| Decision Date | 1995-01-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09321502021753 | K945154 | 000 |
| 09321502021685 | K945154 | 000 |
| 09321502021678 | K945154 | 000 |
| 09321502021661 | K945154 | 000 |
| 09321502014397 | K945154 | 000 |
| 09321502014380 | K945154 | 000 |
| 09321502014373 | K945154 | 000 |
| 09321502014366 | K945154 | 000 |
| 09321502014335 | K945154 | 000 |
| 09321502014328 | K945154 | 000 |
| 09321502014304 | K945154 | 000 |
| 09321502021692 | K945154 | 000 |
| 09321502021708 | K945154 | 000 |
| 09321502014465 | K945154 | 000 |
| 09321502063425 | K945154 | 000 |
| 09321502063418 | K945154 | 000 |
| 09321502063401 | K945154 | 000 |
| 09321502063395 | K945154 | 000 |
| 09321502063388 | K945154 | 000 |
| 09321502063371 | K945154 | 000 |
| 09321502021739 | K945154 | 000 |
| 09321502021722 | K945154 | 000 |
| 09321502021715 | K945154 | 000 |
| 09321502014090 | K945154 | 000 |