K770407 is an FDA 510(k) clearance for the SHIELD, DENTAL X-RAY, PROTECTIVE. This device is classified as a Apron, Protective (Class I - General Controls, product code IWO).
Submitted by Worldwide Dental, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 15, 1977, 11 days after receiving the submission on March 4, 1977.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.6500.
| 510(k) Number | K770407 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 1977 |
| Decision Date | March 15, 1977 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IWO — Apron, Protective |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.6500 |