510(k) K003857 ยท JOW Sleeve, Limb, Compressible
STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES
| Applicant | Sterilmed, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Oct 18, 2001 |
| Received | Dec 13, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003857
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2009 | Sterilmed Inc Compression Sleeves
Model #'s:
HUNDVT10-1 and
KEN5329
The SterilMed Intermittent Compression Sleeve, 400 series used in conjunction with the Talley DVT-275 pump is indicated for any person that is a Terminated |
JOW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.