The following data is part of a premarket notification filed by Medical Device Services with the FDA for Reprocessed Used Disposable Arthroscopic Blades And Burs.
Device ID | K022744 |
510k Number | K022744 |
Device Name: | REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS |
Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
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 | HWE |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-08-19 |
Decision Date | 2002-09-18 |
Summary: | summary |