The following data is part of a premarket notification filed by Compression Therapy Concepts with the FDA for Vascopress Sequential Dvt Pump.
Device ID | K102940 |
510k Number | K102940 |
Device Name: | VASCOPRESS SEQUENTIAL DVT PUMP |
Classification | Sleeve, Limb, Compressible |
Applicant | COMPRESSION THERAPY CONCEPTS 35 JAMES WAY Eatontown, NJ 07724 |
Contact | Leonard Nass |
Correspondent | Leonard Nass COMPRESSION THERAPY CONCEPTS 35 JAMES WAY Eatontown, NJ 07724 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-10-04 |
Decision Date | 2011-01-20 |