The following data is part of a premarket notification filed by Medical Device Services with the FDA for Reprocesses Used Disposable Sequential Compression Sleeves/wraps.
Device ID | K022753 |
510k Number | K022753 |
Device Name: | REPROCESSES USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS |
Classification | Sleeve, Limb, Compressible |
Applicant | MEDICAL DEVICE SERVICES 144 WEST BRIGHAM RD. BLDG E St. George, UT 84790 |
Contact | Mark Aldana |
Correspondent | Mark Aldana MEDICAL DEVICE SERVICES 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 | 2002-08-19 |
Decision Date | 2002-11-14 |
Summary: | summary |