The following data is part of a premarket notification filed by Medical Instruments Technology, Inc. with the FDA for Kendall, Sequential Compression Device; Huntleigh, Flowtron; Venaflow; Acufex; Alps; Sheepskin.
| Device ID | K012614 |
| 510k Number | K012614 |
| Device Name: | KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN |
| Classification | Sleeve, Limb, Compressible |
| Applicant | MEDICAL INSTRUMENTS TECHNOLOGY, INC. 385 NORTH 3050 EAST St. George, UT 84790 |
| Contact | Jack Speer |
| Correspondent | Jack Speer MEDICAL INSTRUMENTS TECHNOLOGY, INC. 385 NORTH 3050 EAST St. George, UT 84790 |
| 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 | 2002-05-01 |
| Summary: | summary |