The following data is part of a premarket notification filed by Adven Medical with the FDA for Reprocessed Used Disposable Sequential Compression Sleeves/wraps.
Device ID | K012675 |
510k Number | K012675 |
Device Name: | REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS |
Classification | Sleeve, Limb, Compressible |
Applicant | ADVEN MEDICAL 1001 SLATON HWY. Lubbock, TX 79404 |
Contact | Mark W Aldana |
Correspondent | Mark W Aldana ADVEN MEDICAL 1001 SLATON HWY. Lubbock, TX 79404 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-08-14 |
Decision Date | 2002-02-12 |
Summary: | summary |