The following data is part of a premarket notification filed by Radkor, Inc. with the FDA for Radkor Bs-10 And Bs-10t.
| Device ID | K891395 |
| 510k Number | K891395 |
| Device Name: | RADKOR BS-10 AND BS-10T |
| Classification | Holder, Radiographic Cassette, Wall-mounted |
| Applicant | RADKOR, INC. 16610 ASTON ST. Irvine, CA 92714 |
| Contact | Jack E Briggs |
| Correspondent | Jack E Briggs RADKOR, INC. 16610 ASTON ST. Irvine, CA 92714 |
| Product Code | IXY |
| CFR Regulation Number | 892.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-14 |
| Decision Date | 1989-04-03 |