The following data is part of a premarket notification filed by O.r. Concepts, Inc. with the FDA for Trocar.
Device ID | K914377 |
510k Number | K914377 |
Device Name: | TROCAR |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | O.R. CONCEPTS, INC. 200 N. OAK ST. Roanoke, TX 76262 |
Contact | John Mayall |
Correspondent | John Mayall O.R. CONCEPTS, INC. 200 N. OAK ST. Roanoke, TX 76262 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-01 |
Decision Date | 1991-10-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TROCAR 86526529 4812059 Live/Registered |
FERADYNE OUTDOORS, LLC 2015-02-06 |