The following data is part of a premarket notification filed by Alliance Medical Corp. with the FDA for Reprocessed Endoscopic Trocars And Cannulas.
Device ID | K024015 |
510k Number | K024015 |
Device Name: | REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS |
Classification | Laparoscope, General & Plastic Surgery, 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 | NLM |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-04 |
Decision Date | 2003-03-04 |
Summary: | summary |