The following data is part of a premarket notification filed by Hygia Health Services, Inc. with the FDA for Hygia Health Services Reprocessed Huntleigh Flowtron Dvt Sleeve Models Dvt10, Dvt 20, Dvt 30, Dvt 40.
Device ID | K012654 |
510k Number | K012654 |
Device Name: | HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40 |
Classification | Sleeve, Limb, Compressible |
Applicant | HYGIA HEALTH SERVICES, INC. 2800 MILAN CT., SUITE 259 Birmingham, AL 35211 |
Contact | Geoff M Fatzinger |
Correspondent | Geoff M Fatzinger HYGIA HEALTH SERVICES, INC. 2800 MILAN CT., SUITE 259 Birmingham, AL 35211 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-08-13 |
Decision Date | 2002-04-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30817357021807 | K012654 | 000 |
30817357021777 | K012654 | 000 |
30817357021401 | K012654 | 000 |
30817357021340 | K012654 | 000 |
30817357020138 | K012654 | 000 |