The following data is part of a premarket notification filed by Alliance Medical Corp. with the FDA for Reprocessed Unipolar Laparoscopic/endoscopic Instruments.
| Device ID | K012625 |
| 510k Number | K012625 |
| Device Name: | REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Contact | Don Selvey |
| Correspondent | Don Selvey ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-13 |
| Decision Date | 2001-10-22 |
| Summary: | summary |