The following data is part of a premarket notification filed by Sakura Finetek U.s.a., Inc. with the FDA for Sakura Hem-480 Electron Microscopy Processor.
| Device ID | K881165 |
| 510k Number | K881165 |
| Device Name: | SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR |
| Classification | Processor, Tissue, Automated |
| Applicant | SAKURA FINETEK U.S.A., INC. 23440 HAWTHORNE BLVD. SUITE 240 Torrance, CA 90505 |
| Contact | Robert A Clark |
| Correspondent | Robert A Clark SAKURA FINETEK U.S.A., INC. 23440 HAWTHORNE BLVD. SUITE 240 Torrance, CA 90505 |
| Product Code | IEO |
| CFR Regulation Number | 864.3875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-20 |
| Decision Date | 1988-07-01 |