510(k) K945154
- Device
- BA-CPAS
- Applicant
- NOBELPHARMA USA, INC.
- 510(k) number
- K945154
- Product code
- FZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-01-13
- Date received
- 1994-10-21
- Regulation
- 878.3680
- Classification name
- Prosthesis, Nose, Internal
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY EDWARDS
- Address
- 777 Oakmont Ln., Suite 100 Westmont IL US 60559 60559
FDA Registration Numbers#
- 1032347
- 2031444
- 9611993
- 2028632
- 3003847101
- 1037007
- 1928237
- 8031010
- 8010099
- 3003394627
- 2028924
- 3003897287
- 3011050570
- 9611992
- 2029275
- 3008693672
- 3010287685
- 3014579188
- 3006405073
- 3009756327
- 1317188
- 3003790304
- 3005900820
- 1825527
- 3006540014
- 9616024
Source Documents#
Other 510(k) Records For Product Code FZE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241253 | Medicon Epiplating System | Cmf Medicon Surgical, Inc. | 2024-12-12 |
| K161548 | Osseointegrated Fixtures | Southern Implants (Pty), Ltd. | 2016-12-01 |
| K090803 | HANSON MEDICAL FACIAL IMPLANTS | Hanson Medical, Inc. | 2010-06-30 |
| K090630 | NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) | Nobel Biocare AB | 2009-06-02 |
| K071018 | MONARCH NASAL IMPLANT | Hanson Medical, Inc. | 2007-05-25 |
| K041690 | MONARCH NASAL IMPLANT | Hanson Medical, Inc. | 2005-02-11 |
| K021418 | AART NASAL IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-02 |
| K992242 | PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS | Pillar Surgical, Inc. | 1999-11-22 |
| K983755 | NASAL DORSAL SERIES | Surgical Technology Laboratories, Inc. | 1998-11-20 |
| K982753 | SEARE BIOMEDICAL NASAL IMPLANTS | Seare Biomedical Corp. | 1998-09-30 |
| K981833 | SILIMED NASAL L SHAPED IMPLANT | Silimed, LLC | 1998-06-26 |
| K973573 | DURALASTIC ANATOMICAL NASAL IMPLANTS | Hanson Medical, Inc. | 1997-11-13 |
| K971481 | DURALASTIC ANATOMICAL NASAL IMPLANTS | Allied Biomedical Corp. | 1997-07-18 |
| K962824 | IMPLANTECH JEJ PERI-PYRIFORM IMPLANT | Implantech Associates, Inc. | 1996-10-03 |
| K961124 | THE NAUTILUS | Rand Scientific Corp. | 1996-04-19 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases