FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THE DENVER SPLINT
K Number: K791681
·
Decision Oct 22, 1979
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
14
Applicant Total
82
Review Days
55
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Basic Information
- Device Name
- THE DENVER SPLINT
- K Number
- K791681
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.5800
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Xomed, Inc.
- Date Received
- August 28, 1979
- Decision Date
- October 22, 1979
- Product Code
- EPP
- 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 |
|---|---|---|---|
| EPP | Splint, Nasal | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EPP), ordered by most recent decision date.
AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
EXTERNAL NASAL SPLINT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
HOOD NASAL SPLINT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
AMERICAN NASAL SPONGE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Other Clearances by Xomed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002395 | MODEL 30 CLASSIC PNEUMATONOMETER | Dec 11, 2000 | Substantially Equivalent |
| K002987 | REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE | Dec 4, 2000 | Substantially Equivalent |
| K002828 | XPS NITRO SYSTEM | Oct 17, 2000 | Substantially Equivalent |
| K002897 | TITANIUM MIDDLE EAR PROSTHESES | Oct 11, 2000 | Substantially Equivalent |
| K993653 | MICRO-FRANCE TROCARS AND ACCESSORIES | Jun 9, 2000 | Substantially Equivalent |
| K001148 | MEROGEL OTOLOGIC PACK | Jun 3, 2000 | Substantially Equivalent |
| K994262 | FRONTAL SINUS TREPHINATION CANNULA | Feb 8, 2000 | Substantially Equivalent |
| K992855 | XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT | Jan 21, 2000 | Substantially Equivalent |
| K993582 | MODIFICATION TO LASER-SHIELD II | Jan 20, 2000 | Substantially Equivalent |
| K993655 | MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS | Dec 21, 1999 | Substantially Equivalent |