FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SILASTIC NASAL IMPLANT S-TYPE
K Number: K880405
·
Decision Feb 18, 1988
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
41
Applicant Total
74
Review Days
20
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SILASTIC NASAL IMPLANT S-TYPE
- K Number
- K880405
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3680
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Dow Corning Wright
- Date Received
- January 29, 1988
- Decision Date
- February 18, 1988
- Product Code
- FZE
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FZE | Prosthesis, Nose, Internal | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FZE), ordered by most recent decision date.
Medicon Epiplating System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Osseointegrated Fixtures
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HANSON MEDICAL FACIAL IMPLANTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MONARCH NASAL IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MONARCH NASAL IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Dow Corning Wright
| K Number | Device Name | ||
|---|---|---|---|
| K932210 | ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENT | Sep 7, 1994 | Substantially Equivalent for Some Indications |
| K932911 | ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT | Jun 30, 1994 | Substantially Equivalent for Some Indications |
| K934354 | LACEY ALL POLYETHYLENE TIBIAL COMPONENT | Jun 3, 1994 | Substantially Equivalent |
| K932222 | SLT FEMORAL HEAD | May 27, 1994 | Substantially Equivalent |
| K932858 | ORTHOLOC ADVANTIM TIBIAL BASE COMPONENT | Feb 16, 1994 | Substantially Equivalent |
| K930228 | ORTHOLOC ADVANTIM TIBIAL STEM 5 DEGREE | Nov 30, 1993 | Substantially Equivalent |
| K925900 | LACEY REVISION FEMORAL COMPONENT | Aug 24, 1993 | Substantially Equivalent |
| K930189 | ORTHOLOC(R) ADVANTIM(TM) POSTERIOR STAB FEMOR COMP | Aug 6, 1993 | Substantially Equivalent for Some Indications |
| K930188 | ORTHOLOC(R) ADVANTIM(TM) FEMORAL COMPONENT | Aug 3, 1993 | Substantially Equivalent |
| K930190 | ORTHOLOC(R) ADVANTIM(TM) NON-POR COAT FEMOR COMP | Aug 2, 1993 | Substantially Equivalent |