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 |