The following data is part of a premarket notification filed by Contraves Medical Instruments, Inc. with the FDA for Digicell 500.
Device ID | K873252 |
510k Number | K873252 |
Device Name: | DIGICELL 500 |
Classification | Counter, Cell, Automated (particle Counter) |
Applicant | CONTRAVES MEDICAL INSTRUMENTS, INC. 44 MANNING RD. Billerica, MA 01821 |
Contact | David B Bertolami |
Correspondent | David B Bertolami CONTRAVES MEDICAL INSTRUMENTS, INC. 44 MANNING RD. Billerica, MA 01821 |
Product Code | GKL |
CFR Regulation Number | 864.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-17 |
Decision Date | 1987-11-06 |