The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Danniflex Cpm 880(tm).
| Device ID | K900581 |
| 510k Number | K900581 |
| Device Name: | DANNIFLEX CPM 880(TM) |
| Classification | Exerciser, Finger, Powered |
| Applicant | BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Product Code | JFA |
| CFR Regulation Number | 890.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-07 |
| Decision Date | 1990-02-20 |