The following data is part of a premarket notification filed by Compression Therapy Concepts with the FDA for Vasopress Dvt Leg Garments (sterile) Vasopress Dvt Foot Garments (sterile).
| Device ID | K122179 |
| 510k Number | K122179 |
| Device Name: | VASOPRESS DVT LEG GARMENTS (STERILE) VASOPRESS DVT FOOT GARMENTS (STERILE) |
| Classification | Sleeve, Limb, Compressible |
| Applicant | COMPRESSION THERAPY CONCEPTS 555 INDUSTRIAL WAY WEST Eatontown, NJ 07724 -2298 |
| Contact | Leonard Nass |
| Correspondent | Leonard Nass COMPRESSION THERAPY CONCEPTS 555 INDUSTRIAL WAY WEST Eatontown, NJ 07724 -2298 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-23 |
| Decision Date | 2012-08-20 |
| Summary: | summary |