The following data is part of a premarket notification filed by Yamato Medical Corp. with the FDA for Buckys Models Ymb-15a, Ymb-15b And Ymb-15c.
| Device ID | K895034 |
| 510k Number | K895034 |
| Device Name: | BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15C |
| Classification | Holder, Radiographic Cassette, Wall-mounted |
| Applicant | YAMATO MEDICAL CORP. SEIAN KAIKAN BLDG., 26-7 2-CHOME, HYAKUNIN-CHO Shinjuku-ku, Tokyo 169, JP |
| Contact | Mori |
| Correspondent | Mori YAMATO MEDICAL CORP. SEIAN KAIKAN BLDG., 26-7 2-CHOME, HYAKUNIN-CHO Shinjuku-ku, Tokyo 169, JP |
| Product Code | IXY |
| CFR Regulation Number | 892.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-08 |
| Decision Date | 1989-11-15 |