The following data is part of a premarket notification filed by Medical Compression Systems (d.b.n.) Ltd. with the FDA for Slendair 4000 Compression System.
| Device ID | K994057 |
| 510k Number | K994057 |
| Device Name: | SLENDAIR 4000 COMPRESSION SYSTEM |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD. 117 AHUZAH ST. Ra'ananna 43373, IL 43373 |
| Contact | Shoshana Friedman |
| Correspondent | Shoshana Friedman MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD. 117 AHUZAH ST. Ra'ananna 43373, IL 43373 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-30 |
| Decision Date | 2000-03-03 |
| Summary: | summary |