The following data is part of a premarket notification filed by Advanced Surgical Concepts with the FDA for Asc Triport Laparoscopic Access Device.
Device ID | K073719 |
510k Number | K073719 |
Device Name: | ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | ADVANCED SURGICAL CONCEPTS 49 PLAIN ST. North Attleboro, MA 02760 |
Contact | Mary Mcnamara-cullinane |
Correspondent | Mary Mcnamara-cullinane ADVANCED SURGICAL CONCEPTS 49 PLAIN ST. North Attleboro, MA 02760 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-12-31 |
Decision Date | 2008-01-29 |
Summary: | summary |