The following data is part of a premarket notification filed by Hygia Health Services, Inc. with the FDA for Hygia Health Service Reprocessed Kendall Scd Sleeve, Models # 5329, 5330, 5345, 5480.
| Device ID | K012417 |
| 510k Number | K012417 |
| Device Name: | HYGIA HEALTH SERVICE REPROCESSED KENDALL SCD SLEEVE, MODELS # 5329, 5330, 5345, 5480 |
| 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 | 2001-07-30 |
| Decision Date | 2002-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30817357022064 | K012417 | 000 |
| 30817357022033 | K012417 | 000 |
| 30817357020930 | K012417 | 000 |