The following data is part of a premarket notification filed by Ascent Heatlhcare Solutions with the FDA for Reprocessed Restep Compression Sleeves.
| Device ID | K101087 |
| 510k Number | K101087 |
| Device Name: | REPROCESSED RESTEP COMPRESSION SLEEVES |
| Classification | Sleeve, Limb, Compressible |
| Applicant | ASCENT HEATLHCARE SOLUTIONS 10232 SOUTH 51ST STREET Pheonix, AZ 85044 |
| Contact | Amanda Bobcock |
| Correspondent | Amanda Bobcock ASCENT HEATLHCARE SOLUTIONS 10232 SOUTH 51ST STREET Pheonix, 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 | 2010-04-19 |
| Decision Date | 2010-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50885825017502 | K101087 | 000 |
| 50885825017496 | K101087 | 000 |
| 50885825016703 | K101087 | 000 |
| 50885825016680 | K101087 | 000 |