FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EXTERNAL NASAL SPLINT
K Number: K942724
·
Decision Jul 8, 1994
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
14
Applicant Total
14
Review Days
29
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Basic Information
- Device Name
- EXTERNAL NASAL SPLINT
- K Number
- K942724
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.5800
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micromed Development Corp.
- Date Received
- June 9, 1994
- Decision Date
- July 8, 1994
- 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
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
'EXMOOR' ATKINS NASAL SPLINT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Other Clearances by Micromed Development Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K945105 | POLY/PLATINUM WIRE PISTON | May 14, 1996 | Substantially Equivalent |
| K945831 | DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KIT | Jan 20, 1995 | Substantially Equivalent |
| K945242 | NERVE MONITOR ELECTRODES/STIMULATOR PROBES | Dec 27, 1994 | Substantially Equivalent |
| K945104 | MICROMED PARTIAL REGULAR AND PARTIAL OFFSET | Nov 22, 1994 | Substantially Equivalent |
| K945107 | POLY-WIRE PISTON | Nov 22, 1994 | Substantially Equivalent |
| K945108 | POLY PISTON | Nov 22, 1994 | Substantially Equivalent |
| K945106 | MICROMED TOTAL REGULAR AND PARTIAL OFFSET | Nov 22, 1994 | Substantially Equivalent |
| K945438 | EDI-BUR MICRODRILL SYSTEMS | Nov 22, 1994 | Substantially Equivalent |
| K943848 | COLLAR BUTTON VENTURI VENT TUBE | Sep 16, 1994 | Substantially Equivalent |
| K943847 | BOBBIN STYLE VENTURI VENT TUBE | Sep 2, 1994 | Substantially Equivalent |