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 | K052065 |
510k Number | K052065 |
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 | 2005-07-29 |
Decision Date | 2005-08-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00885825018337 | K052065 | 000 |
00885825018191 | K052065 | 000 |
00885825018184 | K052065 | 000 |
00885825018177 | K052065 | 000 |
00885825018160 | K052065 | 000 |
00885825018153 | K052065 | 000 |
00885825018146 | K052065 | 000 |
00885825018139 | K052065 | 000 |
00885825018122 | K052065 | 000 |
00885825018115 | K052065 | 000 |
00885825018108 | K052065 | 000 |
00885825018207 | K052065 | 000 |
00885825018214 | K052065 | 000 |
00885825018320 | K052065 | 000 |
00885825018313 | K052065 | 000 |
00885825018306 | K052065 | 000 |
00885825018290 | K052065 | 000 |
00885825018283 | K052065 | 000 |
00885825018269 | K052065 | 000 |
00885825018252 | K052065 | 000 |
00885825018245 | K052065 | 000 |
00885825018238 | K052065 | 000 |
00885825018221 | K052065 | 000 |
00885825018092 | K052065 | 000 |