The following data is part of a premarket notification filed by Alliance Medical Corp. with the FDA for Alliance Medical Corporation Reprocessed External Fixation Devices.
Device ID | K051554 |
510k Number | K051554 |
Device Name: | ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
Applicant | ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
Contact | Moira Barton |
Correspondent | Moira Barton ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
Product Code | KTT |
Subsequent Product Code | JEC |
Subsequent Product Code | KTW |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-06-13 |
Decision Date | 2005-06-29 |
Summary: | summary |