The following data is part of a premarket notification filed by Medical Compression Systems (d.b.n.) Ltd. with the FDA for Proair 3000 Compression System.
| Device ID | K993758 |
| 510k Number | K993758 |
| Device Name: | PROAIR 3000 COMPRESSION SYSTEM |
| Classification | Sleeve, Limb, Compressible |
| 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 | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-05 |
| Decision Date | 2000-05-19 |
| Summary: | summary |