FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INTRA-ORAL THERMOPLASTIC SHIELD
K Number: K962622
·
Decision Oct 1, 1996
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
24
Applicant Total
41
Review Days
88
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- INTRA-ORAL THERMOPLASTIC SHIELD
- K Number
- K962622
- 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
- July 5, 1996
- Decision Date
- October 1, 1996
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPY), ordered by most recent decision date.
DISPOSABLE THYROID COLLAR
FDA 510(k)
FDA Class 1
·Radiology
THERMOPLASTIC SHIELD
FDA 510(k)
FDA Class 1
·Radiology
UTK-DTE AUTILARY SHIELD
FDA 510(k)
FDA Class 1
·Radiology
AUKULYTE
FDA 510(k)
FDA Class 1
·Radiology
2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)
FDA 510(k)
FDA Class 1
·Radiology
KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)
FDA 510(k)
FDA Class 1
·Radiology
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 |
| 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 |