The following data is part of a premarket notification filed by Medical Device Services, Inc. with the FDA for Compressible Limb Sleeve.
| Device ID | K012979 |
| 510k Number | K012979 |
| Device Name: | COMPRESSIBLE LIMB SLEEVE |
| Classification | Sleeve, Limb, Compressible |
| Applicant | MEDICAL DEVICE SERVICES, INC. 144 WEST BRIGHAM RD. BLDG. E St. George, UT 84790 |
| Contact | Ron Eames |
| Correspondent | Ron Eames MEDICAL DEVICE SERVICES, INC. 144 WEST BRIGHAM RD. BLDG. E 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 | 2001-09-05 |
| Decision Date | 2002-05-08 |
| Summary: | summary |