The following data is part of a premarket notification filed by Davis Lead Aprons, Inc. with the FDA for Davis Lead Apron/radiographic Various Cat. Numbers.
| Device ID | K912378 |
| 510k Number | K912378 |
| Device Name: | DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERS |
| Classification | Shield, Protective, Personnel |
| Applicant | DAVIS LEAD APRONS, INC. 1078 CURTIN ST. Houston, TX 77018 |
| Contact | Davis |
| Correspondent | Davis DAVIS LEAD APRONS, INC. 1078 CURTIN ST. Houston, TX 77018 |
| Product Code | KPY |
| CFR Regulation Number | 892.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-29 |
| Decision Date | 1992-03-18 |