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 | K110004 |
510k Number | K110004 |
Device Name: | ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE |
Classification | Laparoscopic Single Port Access Device |
Applicant | ADVANCED SURGICAL CONCEPTS 355 THIRTEENTH STREET, NW Washington, DC 20004 |
Contact | Jonathan Kahan |
Correspondent | Jonathan Kahan ADVANCED SURGICAL CONCEPTS 355 THIRTEENTH STREET, NW Washington, DC 20004 |
Product Code | OTJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-01-03 |
Decision Date | 2011-01-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05391530440066 | K110004 | 000 |