FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BURGET NASAL STENT
K Number: K942025
·
Decision Oct 27, 1995
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
19
Applicant Total
50
Review Days
549
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Basic Information
- Device Name
- BURGET NASAL STENT
- K Number
- K942025
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3900
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bivona Medical Technologies
- Date Received
- April 26, 1994
- Decision Date
- October 27, 1995
- Product Code
- LWF
- Advisory Committee
- Ear, Nose, Throat
- 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 |
|---|---|---|---|
| LWF | Dilator, Nasal | FDA class 1 | Ear, Nose, Throat |
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Other Clearances by Bivona Medical Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K952700 | SUPERSLICK | Oct 31, 1995 | Substantially Equivalent |
| K944178 | BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES | Oct 27, 1994 | Substantially Equivalent |
| K935053 | BIVONA NASAL TURBINATE STENT | Jul 1, 1994 | Substantially Equivalent |
| K933398 | BIVONA ILLUMINATED ENDOTRACHEAL TUBE | Oct 6, 1993 | Substantially Equivalent |
| K931749 | BIVONA(R) ICU ENDOTRACHEAL TUBE | Aug 10, 1993 | Substantially Equivalent |
| K922665 | BIVONA HYPERFLEX TRACHEOSTOMY TUBE | Jan 7, 1993 | Substantially Equivalent |
| K923878 | BIVONA CUSTOMIZED TRACHEOSTOMY TUBES | Dec 29, 1992 | Substantially Equivalent |
| K920604 | BIVONA TRACHEAL T-TUBE STENT | Jul 27, 1992 | Substantially Equivalent |
| K915761 | BIVONA-COLORADO VOICE PROSTHESIS | Jun 29, 1992 | Substantially Equivalent |
| K915799 | BIVONA SLEEP APNEA TUBE | Feb 3, 1992 | Substantially Equivalent |