The following data is part of a premarket notification filed by Compression Therapy Concepts with the FDA for Vasograd Dvt Compression Garment.
Device ID | K102732 |
510k Number | K102732 |
Device Name: | VASOGRAD DVT COMPRESSION GARMENT |
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 | 2010-09-22 |
Decision Date | 2010-10-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
40815245012064 | K102732 | 000 |