The following data is part of a premarket notification filed by Hygia Health Services, Inc. with the FDA for Hygia Health Services Reprocessed Nu Tech Combo, Model Left Limb And Right Limb.
| Device ID | K012956 |
| 510k Number | K012956 |
| Device Name: | HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB AND RIGHT LIMB |
| 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 | 2001-09-04 |
| Decision Date | 2002-04-11 |
| Summary: | summary |