The following data is part of a premarket notification filed by Arbo Medical, Inc. with the FDA for Clem Tm.
| Device ID | K902788 |
| 510k Number | K902788 |
| Device Name: | CLEM TM |
| Classification | Protector, Transducer, Dialysis |
| Applicant | ARBO MEDICAL, INC. 3728 PLAZA DR. Ann Arbor, MI 48108 |
| Contact | Dawn Moore |
| Correspondent | Dawn Moore ARBO MEDICAL, INC. 3728 PLAZA DR. Ann Arbor, MI 48108 |
| Product Code | FIB |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-26 |
| Decision Date | 1990-09-12 |