The following data is part of a premarket notification filed by Arjohuntleigh Polska Sp Z.o.o. with the FDA for Flowtron Foot Garment-regular-sterile Flowtron Foot Garment-large-sterile.
| Device ID | K122330 |
| 510k Number | K122330 |
| Device Name: | FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE |
| Classification | Sleeve, Limb, Compressible |
| Applicant | ARJOHUNTLEIGH POLSKA SP Z.O.O. 35 PORTMANMOOR ROAD Cardiff, GB Cf24 5hn |
| Contact | David Moynham |
| Correspondent | David Moynham ARJOHUNTLEIGH POLSKA SP Z.O.O. 35 PORTMANMOOR ROAD Cardiff, GB Cf24 5hn |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-02 |
| Decision Date | 2012-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15055982700808 | K122330 | 000 |
| 15055982700778 | K122330 | 000 |