The following data is part of a premarket notification filed by Hygia Health Services, Inc. with the FDA for Hygia Health Services Reprocessed Kendall Scd Express Sleeves/foot Cuffs.
| Device ID | K053575 |
| 510k Number | K053575 |
| Device Name: | HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS |
| Classification | Sleeve, Limb, Compressible |
| Applicant | HYGIA HEALTH SERVICES, INC. 434 INDUSTRIAL LN. Birmingham, AL 35211 |
| Contact | Kyle Ferguson |
| Correspondent | Kyle Ferguson HYGIA HEALTH SERVICES, INC. 434 INDUSTRIAL LN. 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 | 2005-12-22 |
| Decision Date | 2006-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30817357022330 | K053575 | 000 |
| 30817357021036 | K053575 | 000 |
| 30817357020992 | K053575 | 000 |
| 30817357020954 | K053575 | 000 |
| 30817357020947 | K053575 | 000 |
| 30817357020770 | K053575 | 000 |
| 30817357020404 | K053575 | 000 |
| 30817357020268 | K053575 | 000 |
| 30817357020169 | K053575 | 000 |
| 30817357021111 | K053575 | 000 |
| 30817357021210 | K053575 | 000 |
| 30817357021227 | K053575 | 000 |
| 30817357021975 | K053575 | 000 |
| 30817357021906 | K053575 | 000 |
| 30817357021890 | K053575 | 000 |
| 30817357021654 | K053575 | 000 |
| 30817357021555 | K053575 | 000 |
| 30817357021449 | K053575 | 000 |
| 30817357021364 | K053575 | 000 |
| 30817357021326 | K053575 | 000 |
| 30817357020121 | K053575 | 000 |