The following data is part of a premarket notification filed by Biomedical Horizons, Inc. with the FDA for Biomedical Horizons Inc. Compression Pump, Model 651.
| Device ID | K971892 |
| 510k Number | K971892 |
| Device Name: | BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 651 |
| Classification | Sleeve, Limb, Compressible |
| Applicant | BIOMEDICAL HORIZONS, INC. 1331 HORTON RD. P.O. BOX 889 Jackson, MI 49203 |
| Contact | William J Donahue |
| Correspondent | William J Donahue BIOMEDICAL HORIZONS, INC. 1331 HORTON RD. P.O. BOX 889 Jackson, MI 49203 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-22 |
| Decision Date | 1998-08-05 |