The following data is part of a premarket notification filed by Advanced Surgical Concepts (asc) with the FDA for Omniport.
Device ID | K002013 |
510k Number | K002013 |
Device Name: | OMNIPORT |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | ADVANCED SURGICAL CONCEPTS (ASC) 49 PLAIN ST. North Attleboro, MA 02760 |
Contact | Mary Mcnamara-cullinane |
Correspondent | Mary Mcnamara-cullinane ADVANCED SURGICAL CONCEPTS (ASC) 49 PLAIN ST. North Attleboro, MA 02760 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-07-03 |
Decision Date | 2000-09-29 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OMNIPORT 78875954 3211390 Live/Registered |
E+E Elektronik Ges.m.b.H. 2006-05-03 |
OMNIPORT 78040144 not registered Dead/Abandoned |
Lexicon Media Communications, inc. 2000-12-20 |
OMNIPORT 77254736 not registered Dead/Abandoned |
Cellport Systems, Inc. 2007-08-14 |
OMNIPORT 76220609 2875969 Dead/Cancelled |
Advanced Surgical Concepts Limited 2001-03-05 |
OMNIPORT 75665109 not registered Dead/Abandoned |
RCM Technologies, Inc. 1999-03-22 |
OMNIPORT 75141209 not registered Dead/Abandoned |
BDSI, Inc. 1996-07-29 |
OMNIPORT 75141208 not registered Dead/Abandoned |
BDSI, Inc. 1996-07-29 |
OMNIPORT 75105631 not registered Dead/Abandoned |
CellPort Labs, Inc. 1996-05-17 |
OMNIPORT 74402047 not registered Dead/Abandoned |
AT&T CORP. 1993-06-11 |
OMNIPORT 73743642 1540912 Dead/Cancelled |
CMT SYSTEMS 1988-08-01 |