K952233 is an FDA 510(k) clearance for the CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628. This device is classified as a Screen, Leaded, Operator Radiation Protector (Class I - General Controls, product code EAK).
Submitted by Victoreen, Inc. (Cleveland, US). The FDA issued a Cleared decision on June 16, 1995, 35 days after receiving the submission on May 12, 1995.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.6500.
| 510(k) Number | K952233 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 1995 |
| Decision Date | June 16, 1995 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | EAK — Screen, Leaded, Operator Radiation Protector |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.6500 |