The following data is part of a premarket notification filed by Sakura Finetek U.s.a., Inc. with the FDA for Sakura-medscand Sca-1800 Automatic Coverslipper.
Device ID | K882881 |
510k Number | K882881 |
Device Name: | SAKURA-MEDSCAND SCA-1800 AUTOMATIC COVERSLIPPER |
Classification | Coverslips, Microscope Slide |
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 | KES |
CFR Regulation Number | 864.3010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-11 |
Decision Date | 1988-07-28 |