FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT
K Number: K895502
·
Decision Dec 8, 1989
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
14
Applicant Total
13
Review Days
87
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Basic Information
- Device Name
- MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT
- K Number
- K895502
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.5800
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Microbio-Medics, Inc.
- Date Received
- September 12, 1989
- Decision Date
- December 8, 1989
- 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
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 Microbio-Medics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923353 | VENTILATION TUBES W/ HYDROGEL COATING | May 18, 1993 | Substantially Equivalent |
| K922572 | 321Q MINIMUM ENERGY TINNITUS SUPPRESSOR | Nov 2, 1992 | Substantially Equivalent |
| K913276 | MICROTEK MEDICAL'S SOUND STIKS | Oct 21, 1991 | Substantially Equivalent |
| K904239 | SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES | Jun 21, 1991 | Substantially Equivalent |
| K910167 | MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM | Apr 15, 1991 | Substantially Equivalent |
| K900726 | MICROTEK MEDICAL'S BLOOD COLLECTION KIT | May 4, 1990 | Substantially Equivalent |
| K901154 | MICROTEK'S SURGICAL LAMP HANDLE & COVER | Mar 20, 1990 | Substantially Equivalent |
| K895815 | MICROTEK TOTAL OSSICULAR PROTHESIS | Dec 26, 1989 | Substantially Equivalent |
| K895814 | MICROTEK PISTON & WIRE PROSTHESES | Dec 26, 1989 | Substantially Equivalent |
| K885201 | OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT | Apr 19, 1989 | Substantially Equivalent |