The following data is part of a premarket notification filed by Compression Therapy Concepts, Inc. with the FDA for Scd Garment, Model Vp530.
| Device ID | K061967 |
| 510k Number | K061967 |
| Device Name: | SCD GARMENT, MODEL VP530 |
| Classification | Sleeve, Limb, Compressible |
| Applicant | COMPRESSION THERAPY CONCEPTS, INC. 1750 BRIELLE AVE. SUITE B6 Wanamassa, NJ 07712 |
| Contact | Len Nass |
| Correspondent | Len Nass COMPRESSION THERAPY CONCEPTS, INC. 1750 BRIELLE AVE. SUITE B6 Wanamassa, NJ 07712 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-12 |
| Decision Date | 2006-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40815245011173 | K061967 | 000 |
| 40815245011128 | K061967 | 000 |
| 40815245011074 | K061967 | 000 |
| 40815245011029 | K061967 | 000 |