The following data is part of a premarket notification filed by Alliance Medical Corp. with the FDA for Reprocessed Electrophysiology Catheters.
| Device ID | K043392 |
| 510k Number | K043392 |
| Device Name: | REPROCESSED ELECTROPHYSIOLOGY CATHETERS |
| Classification | Catheter, Recording, Electrode, Reprocessed |
| 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 | NLH |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-10 |
| Decision Date | 2005-03-25 |
| Summary: | summary |