FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NASAL AIRWAY SPLINT
K Number: K972092
·
Decision Jul 8, 1997
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
45
Applicant Total
33
Review Days
34
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Basic Information
- Device Name
- NASAL AIRWAY SPLINT
- K Number
- K972092
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4780
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Medical Products, Inc.
- Date Received
- June 4, 1997
- Decision Date
- July 8, 1997
- Product Code
- LYA
- 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 |
|---|---|---|---|
| LYA | Splint, Intranasal Septal | FDA class 1 | Ear, Nose, Throat |
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Other Clearances by Boston Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K091135 | RUTTER SUPRA STOMAL STENTS | Sep 14, 2009 | Substantially Equivalent |
| K972317 | MONTGOMERY THYROPLASTY IMPLANT SYSTEM | Sep 18, 1997 | Substantially Equivalent |
| K972459 | RHINOCELL NASAL PACKINGS | Aug 4, 1997 | Substantially Equivalent |
| K972096 | BIVALVE NASAL SPLINT | Jul 15, 1997 | Substantially Equivalent |
| K972078 | POST-STOP EPISTAXIS CATHETER | Jul 10, 1997 | Substantially Equivalent |
| K972151 | DOYLE COMBO NASAL AIRWAY SPLINT | Jul 7, 1997 | Substantially Equivalent |
| K972082 | CUSTOM NASAL SPLINT | Jul 3, 1997 | Substantially Equivalent |
| K972060 | NASAL SEPTAL BUTTON | Jul 3, 1997 | Substantially Equivalent |
| K972076 | EPI-MAX EPISTAXIS CATHETER | Jun 26, 1997 | Substantially Equivalent |
| K972077 | EPI-STOP EPISTAXIS CATHETER | Jun 26, 1997 | Substantially Equivalent |