The following data is part of a premarket notification filed by Medical Device Technologies, Inc. with the FDA for Manan.
Device ID | K974743 |
510k Number | K974743 |
Device Name: | MANAN |
Classification | Trocar |
Applicant | MEDICAL DEVICE TECHNOLOGIES, INC. 4445 SW 35TH TERRACE SUITE 310 Gainesville, FL 32608 |
Contact | Karl Swartz |
Correspondent | Karl Swartz MEDICAL DEVICE TECHNOLOGIES, INC. 4445 SW 35TH TERRACE SUITE 310 Gainesville, FL 32608 |
Product Code | DRC |
CFR Regulation Number | 870.1390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-12-19 |
Decision Date | 1998-04-06 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MANAN 85868777 4837154 Live/Registered |
Manán Systems, LLC 2013-03-06 |
MANAN 78735673 3176575 Live/Registered |
Manan Medical Products, Inc. 2005-10-18 |