FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT
K Number: K132908
·
Decision Mar 4, 2014
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
41
Review Days
168
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Basic Information
- Device Name
- TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT
- K Number
- K132908
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtec, Inc.
- Date Received
- September 17, 2013
- Decision Date
- March 4, 2014
- Product Code
- IYE
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
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| K955236 | GREEN TEC-2100 | May 24, 1996 | Substantially Equivalent |
| K954705 | ACRYSTEEL BLOCKING TRAY | Jan 5, 1996 | Substantially Equivalent |
| K954456 | THERMOPLASTIC SHIELD | Dec 21, 1995 | Substantially Equivalent |
| K954225 | MED-TEC HAND GRIP | Nov 14, 1995 | Substantially Equivalent |