The following data is part of a premarket notification filed by Hygia Health Services, Inc. with the FDA for Hygia Health Services Reprocessed Nutech Calf Wrap.
| Device ID | K012657 |
| 510k Number | K012657 |
| Device Name: | HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP |
| 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 |