The following data is part of a premarket notification filed by Ascent Healthcare Solutions with the FDA for Reprocessed Compression Sleeves.
| Device ID | K100909 |
| 510k Number | K100909 |
| Device Name: | REPROCESSED COMPRESSION SLEEVES |
| Classification | Sleeve, Limb, Compressible |
| Applicant | ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Contact | Ramona Kulik |
| Correspondent | Ramona Kulik ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-01 |
| Decision Date | 2010-07-23 |
| Summary: | summary |