The following data is part of a premarket notification filed by Alliance Medical Corp. with the FDA for Reprocessed Ultrasonic Scalpels.
| Device ID | K043358 |
| 510k Number | K043358 |
| Device Name: | REPROCESSED ULTRASONIC SCALPELS |
| Classification | Scalpel, Ultrasonic, Reprocessed |
| Applicant | ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Contact | Elizabeth Renken |
| Correspondent | Elizabeth Renken ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Product Code | NLQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-06 |
| Decision Date | 2005-06-06 |
| Summary: | summary |