FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
NASAL SEPTAL BUTTON
K Number: K850492
·
Decision Mar 7, 1985
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
11
Applicant Total
8
Review Days
27
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Basic Information
- Device Name
- NASAL SEPTAL BUTTON
- K Number
- K850492
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Santa Barbara Medco, Inc.
- Date Received
- February 8, 1985
- Decision Date
- March 7, 1985
- Product Code
- LFB
- Advisory Committee
- Unknown
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| LFB | Button, Nasal Septal | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LFB), ordered by most recent decision date.
BLOM-SINGER SEPTAL PERFORATION PROSTHESIS
FDA 510(k)
FDA Unclassified
·Unknown
SILMED NASAL SEPTAL BUTTON
FDA 510(k)
FDA Unclassified
·Unknown
MICROMEDICS NASAL SEPTAL BUTTON
FDA 510(k)
FDA Unclassified
·Unknown
NASAL SEPTAL BUTTON
FDA 510(k)
FDA Unclassified
·Unknown
HOOD NASAL SEPTAL BUTTON
FDA 510(k)
FDA Unclassified
·Unknown
INVOTEC SEPTAL BUTTON
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Santa Barbara Medco, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K842483 | SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC | Aug 31, 1984 | Substantially Equivalent |
| K823921 | PHYSICIANS CHOICE SILICONE EAR PUTTY | Mar 28, 1983 | Substantially Equivalent |
| K821187 | MEDCO CUSTOM EAR PROTECTOR MOLD KIT | May 27, 1982 | Substantially Equivalent |
| K812069 | BORES* DEPTH GAUGE | Aug 31, 1981 | Substantially Equivalent |
| K812071 | RK IV SURGICAL BLADES | Aug 31, 1981 | Substantially Equivalent |
| K812070 | BORES* ADJUSTABLE BLADE HOLDER | Aug 18, 1981 | Substantially Equivalent |
| K802638 | OTOLOGICAL VENTILATION TUBES | Nov 12, 1980 | Substantially Equivalent |