FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
HOOD NASAL SEPTAL BUTTON
K Number: K920994
·
Decision May 15, 1992
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
11
Applicant Total
19
Review Days
74
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Basic Information
- Device Name
- HOOD NASAL SEPTAL BUTTON
- K Number
- K920994
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hood Laboratories
- Date Received
- March 2, 1992
- Decision Date
- May 15, 1992
- 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
INVOTEC SEPTAL BUTTON
FDA 510(k)
FDA Unclassified
·Unknown
OMEGA NASAL SEPTAL BUTTON
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Hood Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K921452 | ACOUSTIC RHINOMETER | Jul 8, 1993 | Substantially Equivalent |
| K905703 | KRUPIN EYE VALVE WITH DISK | Mar 15, 1991 | Substantially Equivalent |
| K904821 | ELIACHAR MODIFIED ESOPHAGEAL STENT | Jan 14, 1991 | Substantially Equivalent |
| K897049 | GIBSON ENDOLYMPHATIC SHUNT | Mar 16, 1990 | Substantially Equivalent |
| K897059 | HOOD SPEAKING VALVE | Mar 12, 1990 | Substantially Equivalent |
| K893866 | HOOD PEDIATRIC TRACHEOSTOMY TUBE | Aug 7, 1989 | Substantially Equivalent |
| K884810 | SILICONE LARYNGEAL STENT | May 10, 1989 | Substantially Equivalent |
| K890599 | HOOD NASAL SPLINT | Mar 17, 1989 | Substantially Equivalent |
| K885125 | KRUPIN EYE VALVE W/SCLERAL BUCKLE | Jan 24, 1989 | Substantially Equivalent |
| K882430 | HOOD TRACHEAL STOMA BUTTON | Jun 28, 1988 | Substantially Equivalent |