Thermoplastic Shield
by Medtec LLC
510(k) K954456
Thermoplastic Shield is a Class I device made by Medtec LLC, cleared under FDA 510(k) K954456 on 21 Dec 1995, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK954456 | Date21 Dec 1995 | StatusActive |
Official records
- FDA 510(k) database K954456
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KPY
- FDA applicant
- Medtec, Inc.
- Device class
- Class I
- Regulation
- 21 CFR Part 892.6500
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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