The following data is part of a premarket notification filed by Arbor Technologies, Inc. with the FDA for Clyde (tm) Filtration System.
| Device ID | K864113 |
| 510k Number | K864113 |
| Device Name: | CLYDE (TM) FILTRATION SYSTEM |
| Classification | Filter, Infusion Line |
| Applicant | ARBOR TECHNOLOGIES, INC. 3728-1 PLAZA DR. Ann Arbor, MI 48104 |
| Contact | Dawn I Moore |
| Correspondent | Dawn I Moore ARBOR TECHNOLOGIES, INC. 3728-1 PLAZA DR. Ann Arbor, MI 48104 |
| Product Code | FPB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-21 |
| Decision Date | 1987-02-04 |