The following data is part of a premarket notification filed by Clear Medical, Inc. with the FDA for Clearmedical/novamedix Avi Foot Cover, Pair, Regular & Large Size.
| Device ID | K012612 |
| 510k Number | K012612 |
| Device Name: | CLEARMEDICAL/NOVAMEDIX AVI FOOT COVER, PAIR, REGULAR & LARGE SIZE |
| Classification | Sleeve, Limb, Compressible |
| Applicant | CLEAR MEDICAL, INC. 1776 136TH PL. NE Bellevue, WA 98005 |
| Contact | Richard Radford |
| Correspondent | Richard Radford CLEAR MEDICAL, INC. 1776 136TH PL. NE Bellevue, WA 98005 |
| 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 | 2002-02-06 |
| Summary: | summary |