FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THERMOPLASTIC SHIELD
K Number: K954456
·
Decision Dec 21, 1995
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
24
Applicant Total
41
Review Days
87
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Basic Information
- Device Name
- THERMOPLASTIC SHIELD
- K Number
- K954456
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.6500
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medtec, Inc.
- Date Received
- September 25, 1995
- Decision Date
- December 21, 1995
- Product Code
- KPY
- 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 |
|---|---|---|---|
| KPY | Shield, Protective, Personnel | FDA class 1 | Radiology |
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Other Clearances by Medtec, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K132908 | TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT | Mar 4, 2014 | Substantially Equivalent |
| K111340 | HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM | Jun 28, 2011 | Substantially Equivalent |
| K093738 | MRI PATIENT POSITIONING DEVICES | May 14, 2010 | Substantially Equivalent |
| K974703 | CARBON FIBER BREAST BOARD | Mar 10, 1998 | Substantially Equivalent |
| K974700 | MATRIX MT-MX3 | Mar 4, 1998 | Substantially Equivalent |
| K973842 | CARBON FIBER CONFORMAL COUCH TOP | Dec 5, 1997 | Substantially Equivalent |
| K962622 | INTRA-ORAL THERMOPLASTIC SHIELD | Oct 1, 1996 | Substantially Equivalent |
| K955236 | GREEN TEC-2100 | May 24, 1996 | Substantially Equivalent |
| K954705 | ACRYSTEEL BLOCKING TRAY | Jan 5, 1996 | Substantially Equivalent |
| K954225 | MED-TEC HAND GRIP | Nov 14, 1995 | Substantially Equivalent |