The following data is part of a premarket notification filed by Innovative Products Mfg. with the FDA for Mobile X-ray Personnel Protective Screens.
| Device ID | K896949 |
| 510k Number | K896949 |
| Device Name: | MOBILE X-RAY PERSONNEL PROTECTIVE SCREENS |
| Classification | Screen, Leaded, Operator Radiation Protector |
| Applicant | INNOVATIVE PRODUCTS MFG. BOX 447 248 DODGE AVENUE East Haven, CT 06512 |
| Contact | Kenney, Sr |
| Correspondent | Kenney, Sr INNOVATIVE PRODUCTS MFG. BOX 447 248 DODGE AVENUE East Haven, CT 06512 |
| Product Code | EAK |
| CFR Regulation Number | 892.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-13 |
| Decision Date | 1990-02-16 |