The following data is part of a premarket notification filed by Contraves Medical Instruments, Inc. with the FDA for Digicell 300 System.
| Device ID | K873271 |
| 510k Number | K873271 |
| Device Name: | DIGICELL 300 SYSTEM |
| 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 |